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- 2025-12-23 19:13:29
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- Joint development & production of DM Combi with SK Chem & AZ
- by Kim, Jin-Gu Jun 21, 2023 10:06am
- From left, Kim Yun-ho, CEO of Pharma Business, SK Chemicals CEO Ahn Jae-hyun, SK Discovery Vice Chairman Choi Chang-won, AstraZeneca International Market China Senior Vice Chairman Leon Wang, AstraZeneca Asia Regional President Sylvia Varela, AstraZeneca International Market Financial Director Ankush Nandra Vice Chairman, Kim Sang-pyo, President and CEO of AstraZeneca Korea디스커버리 최창원 부회장, 아스트라제네카 인터내셔널마켓·중국 총괄 레옹 왕 수석부회장, 아스트라제네카 아시아지역 총괄 실비아 바렐라 사장, 아스트라제네카 인터내셔널마켓 재무총괄 안쿠시 난드라 부회장, 한국아스트라제네카 김상표 대표이사 사장. SK Chemicals plans to supply products developed and produced to 12 global countries through AZ. SK Chemicals announced on the 19th that it has produced the first commercial product of a diabetes complex jointly developed with AstraZeneca. SK Chemicals explained that it recently held an event to inspect and celebrate the global joint business of the two companies with the participation of SK Discovery Vice Chairman Choi Chang-won, SK Chemicals President Ahn Jae-Hyun, AZ Senior Vice Chairman Leon Wang, and Korea AstraZeneca President Kim Sang-pyo. SK Chemicals is one of the subsidiaries of SK Discovery. The event was prepared to check the progress of SK Chemicals and AstraZeneca's joint development of diabetes complexes and to celebrate the production of the first commercial product. The two companies signed an agreement in 2020 to jointly develop DM combinations. This product is said to be a combination of SGLT-2 inhibitors and DPP-4 inhibitors for diabetes treatment. In Korea, AstraZeneca Korea plans to apply for product approval soon. AstraZeneca supplied APIs to SK Chemicals and invested in R&D. SK Chemicals was in charge of R&D and domestic clinical trials. SK Chemicals is expected to take over the production of this product in the future. The two companies plan to go through approval procedures in global countries including Korea through AstraZeneca's global business network for products developed and produced by SK Chemicals. am. After that, it plans to gradually expand the supply countries. "We are delighted to cooperate with SK Chemicals, which has excellent production and quality management technology, through this project," said Leon Wang, senior vice president in charge of international markets and China at AstraZeneca. He said, "Korea is a key country in AstraZeneca's innovation, and I hope that we will be able to provide valuable treatments to patients through various cooperation in the future." Vice Chairman Choi Chang-won of SK Discovery said, "SK Chemicals' pharmaceutical technology and production capacity have been recognized, and we have laid the foundation for supplying medicines to more countries." "Starting with the diabetes combination drug, we will make efforts to ensure that the two companies grow together through continuous cooperation and communication," he said.
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- Camzyos, which prevents sudden cardiac death in young people
- by Jung, Sae-Im Jun 21, 2023 05:51am
- Korea BMS Pharmaceuticals (CEO Lee Hye-young) announced on the 20th that it held a domestic approval meeting for Camzyos, a treatment for 'obstructive hypertrophic cardiomyopathy (oHCM)', on the 19th and introduced its clinical value. Obstructive hypertrophic cardiomyopathy is a severe and rare heart disease in which thickened left ventricular muscle blocks blood flow to the whole body, causing shortness of breath, heart failure, fainting, and sudden cardiac death. Camzyos, developed by Korea BMS Pharmaceuticals, selectively inhibits excessive cross-linking of cardiac myosin and actin, which is the cause of obstructive hypertrophic cardiomyopathy. On May 23, it received approval from the Ministry of Food and Drug Safety as a treatment for improving motor function and symptoms in patients with symptomatic (mild and moderate) obstructive hypertrophic cardiomyopathy. In the first presentation, Professor Kim Hyung-gwan of Seoul National University Hospital's Department of Cardiovascular Medicine mentioned the overall overview of hypertrophic cardiomyopathy in Korea, the treatment environment, and unmet needs in the current treatment strategy. Professor Kim explained, "In the myocardium, two proteins, actin, and myosin, are connected to each other to contract the heart, and then separate again to relax the myocardium, acting as a pump, which is the function of the heart." "In patients with hypertrophic cardiomyopathy, actin, and myosin are excessively connected to each other, causing excessive contraction of the myocardium, and this excessive connection makes it difficult for the myocardium to relax," he explained. According to Professor Kim, hypertrophic cardiomyopathy is one of the main causes of sudden cardiac death in young people, and its prevalence is gradually increasing in Korea along with the expansion of echocardiography. This disease is divided into two types, obstructive and non-obstructive, and 15-20% of all patients are classified as obstructive hypertrophic cardiomyopathy. Treatment of obstructive hypertrophic cardiomyopathy is very limited, focusing on symptom relief and prevention of complications. He added that some beta-blockers and calcium channel blockers, which are representatively used drugs, are difficult to expect long-term improvement in symptoms and the effect is not as good as expected, so there is a high unmet demand. If drug treatment does not work, surgical myocardial resection or alcoholic septal resection is considered, but the explanation is that the risks of surgery are not small. Camzyos is a new class of treatment that directly acts on the excessive binding of actin-myosin, which is the root cause of obstructive hypertrophic cardiomyopathy. Kamgios improves left ventricular outflow tract obstruction and normalizes excessive cardiac contractility by reducing the number of excessive cross-links of actin and myosin. This restores left ventricular diastolic function, reduces ventricular filling pressure, and improves myocardial energy overconsumption. The clinical trial that served as the basis for Camzyos approval is the EXPLORER-HCM study. In this clinical trial, Camzyos improved the primary endpoints, patient symptoms (NYHA grade), and exercise capacity (maximum oxygen intake, pVO2) more than twice as compared to the placebo. Twenty percent of the Camzyos group achieved both NYHA ratings and pVO2 improvements. After exercise, the index of left ventricular outflow tract obstruction also decreased more than 4-fold. Seven out of 10 patients treated with Camzyos improved their index to such an extent that they did not consider surgery, and maintained consistent effects for 30 weeks. “Obstructive hypertrophic cardiomyopathy is a rare and serious disease that can cause sudden cardiac death without warning in young people,” said Lee Hye-young, CEO of BMS Korea Pharmaceutical Korea. “We are delighted to be able to present a new treatment paradigm for oHCM with the approval of Camzyos.”
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- [two thousandth]Toxins accumulated in Soyul's body every day
- by Jung, Sae-Im Jun 21, 2023 05:50am
- Soyul, who turned 5 this year, stopped growing at 80cm and is no longer growing. Her arms and legs are not straight and straight. If you try to forcefully stretch it, you could break a bone. This is because Soyul's bone density is low enough to be found in an elderly person in his 80s. Soyul also has carpal tunnel syndrome, which affects 7 out of 10 people in their 70s. Born in 2019 at 2.8kg, Soyul met the world with a dislocated hip joint. When she was about six months old, she also suffered an inguinal hernia where her intestines protruded into her groin. Soyul's small vertebrae seemed to be slightly bent. Her parents, who were worried that their child was not growing well from the inside out, thought that Soyul might be ill and went to the local hospital. The parents were a little relieved when the doctor said, "If it's not for a 0.01% rare disease, it will grow well." However, Soyul was diagnosed with a 0.01% rare disease. It was a disease called 'mucolipidosis type 2', which has one of the highest numbers of patients worldwide. Low growth, hip dislocation, scoliosis, umbilical/inguinal hernia, and many other symptoms that Soyul had to experience before she turned one year old were all due to this disease. There is no cure for this disease, so it is an incurable disease that gradually worsens and leads to death before entering adolescence. Soyul is a condition in which a large number of acidic polysaccharides and glycolipids accumulate in the body due to a lack of enzymes due to abnormalities in certain genes. Broadly speaking, it belongs to one of the lysosomal storage diseases. The complications that arise from this are so diverse that it is difficult for doctors to clearly define which symptoms will appear. Some children may develop abnormalities in their heart valves, severe middle ear infections, or cloudy corneas. Like Soyul, you may have frequent high fevers or problems with your joints. Main symptoms of mucolipidosis type 2 (source: Korea Centers for Disease Control and Prevention) “Symptoms appear differently depending on where the toxin called mucolipid accumulates. Even looking at children with the same disease as Soyul, the main symptoms are very different. Soyul’s joints are the most severe. "I can't stretch my arms straight out. I can't live, I can't touch my ears with my hands. I also bent my fingers and toes inward, but it got better as I rehabilitated. I have no choice but to keep rehabilitating so that it doesn't get worse." Due to a rare disease, Soyul lives with frequent high fevers and the risk of pneumonia. (Photo: courtesy of the patient Thanks to hard rehabilitation last year and last year, Soyul even walked on two legs with the help of a walker. My height, which was said to be no longer growing, has grown a little. Her mother's thrill at seeing her like that did not last long. Because Soyul's illness is still ongoing. Soyul practicing walking. (Photo: courtesy of the patient "I told the doctor, and I heard that it was only that a child with mucolipidosis was able to walk, and that the disease did not disappear. In the end, there was no medicine, so the symptoms reappeared and worsened. Oh, I really shouldn't have hope. That's it... I wanted to." Reality sometimes does not allow for even the slightest hope. Seeing the children with the same disease as So-yul leave one by one, So-yul's mother swallows her sadness every time. She is terrified of what may happen to So-yul when and where. According to a thesis examining the clinical characteristics of children diagnosed with this disease in Korea ('Analysis of clinical characteristics of mucosteatosis patients in Korea, including one case of mucosteatosis type 2 diagnosed with a new GNPTAB gene mutation'), Most are diagnosed in infancy, around age 2, and die within 10 years of age. Respiratory problems were also cited as the leading cause of death. "There is a group chat room for parents suffering from the same disease as Soyul to share information. There were 9 children... 2 of them left us. One child who recently left turned 11 and told us It was like a pillar. That's why when Soyul is struggling with rehabilitation and cries sadly, I suddenly think, 'Is it true that I'm doing well right now?' I couldn't give up hope when I saw that I could walk, learn how to use a straw, and understand almost everything my mom and dad say because my cognitive abilities improved." Soyul is a 5-year-old girl who likes to play on the playground with her friends the most. Seeing Soyul's smiling face, her mother finds hope in her again. Soyul can feel more joy in the world, her mother informs her of So-yul's illness through SNS and begs him to make a cure for her. And not too long ago, Soyul's mother said she got a really miraculous phone call from her. She was informed that Soyul was going to develop a cure for her illness at Samsung Seoul Hospital, so she asked to participate. "Somehow, the story of Samsung Electronics Chairman Lee Jae-yong's impersonation account became a lot of articles, but in fact, I didn't know that the account was an impersonation account (laughs). It's just that Samsung Seoul Hospital made a mucopolysaccharidosis treatment that is related to mucolipidosis, so Samsung Seoul I think a hospital could make a cure for my child, because, as you know, this disease is so rare that there are less than 100 patients worldwide, and I wonder who would spend their time and money on this cheap bottle. I almost gave up and sent a DM (direct message) to Chairman Lee Jae-yong's (impersonated) account every day, but I was so surprised to hear this." Soyul will undergo various tests to develop a treatment at Samsung Seoul Hospital next month. You will also receive an injection to protect your weakened bones. She plans to travel to Jeju Island with her family after the 5 days and 4 nights of examination and treatment. For Soyul, whose respiratory system is particularly weak, and her winter is dangerous, her family diligently goes on a trip to remember her in the summer. "I'm going to play hard with Soyul this summer. And I'll work harder on Instagram and YouTube so that I can publicize Soyul's illness and take classes that Soyul finds interesting. If anyone has to do something, Soyul and I will I think it should be done. It would be great if more people came to know about this disease and progressed in a good direction.” So that Soyul and her children with mucolipidosis can welcome healthy teenagers. So that we can see Soyul's smiling face every year. Her mom gives her strength even today. Soyul smiles at her mother (photo: courtesy of the patient
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- ALS drug Teglutik may be prescribed at general hospitals
- by Eo, Yun-Ho Jun 20, 2023 05:35am
- SK Chemical’s Lou Gehrig's disease treatment ‘Teglutik’ can now be prescribed at general hospitals in Korea. According to industry sources, Teglutik (riluzole) passed the drug committees (DCs) of tertiary hospitals including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, as well as medical institutions such as Pusan National University Hospital The drug, which was released this year, was approved by the Ministry of Food and Drug Safety in May last year to extend the survival period or delay tracheostomy in patients with amyotrophic lateral sclerosis (ALS) ALS, which is also commonly referred to as Lou Gehrig's disease, is a neurodegenerative disorder that results in the progressive loss of motor neurons, leading to paralysis in the limbs and breathing. So far, there is no cure for Lou Gehrig's disease itself, however, symptomatic treatments such as Teglutik are available to slow down symptoms. Teglutik comes in a suspension formulation that allows an easier oral intake for patients suffering from swallowing disorders. The company explained that Teglutik offers an improved convenience in intake compared to existing treatments. Meanwhile, other riluzole treatments available in the market are Rilutek (Sanofi) and Yooritek Tab. Based on IQVIA, Rilutek sold KRW 3.7 billion and Yooritek KRW 2.5 billion in 2021. Teglutik, the only riluzole suspension formulation available, was listed for insurance reimbursement in January last year. The ceiling insurance price is KRW 133,970 per vial for 15-day use. Therefore, the price is the same as the price of existing tablet formulations (KRW 4,499 per day) in terms of daily dosage. Therefore, what changes will occur with SK Chemicals' entry into the riluzole market that had been shared by Sanofi and Yoo Young Pharmaceutical remains to be seen.
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- SK Biopharmaceuticals’ Cenobamate approved in Canada
- by Chon, Seung-Hyun Jun 19, 2023 06:00am
- SK Biopharmaceuticals announced on the 15th that Cenobamate, a new drug for epilepsy, has received marketing approval from the Canadian Department of Health. Cenobamate's commercialization in Canada is being handled by Paladin Labs, a local pharmaceutical company. Cenobamate is a new drug for epilepsy that SK Biopharmaceuticals is independently selling in the US. It was approved by the US FDA in 2019. Cenobamate was independently carried out by SK Biopharmaceuticals in the entire process from initial development to U.S. Food and Drug Administration (FDA) approval. It is prescribed for adult epileptic patients with partial seizure symptoms. It is a mechanism of action that relieves seizure symptoms by simultaneously regulating two targets related to excitatory and inhibitory signaling, which cause epilepsy. SK Biopharmaceuticals expects that "Cenobamate will receive approval in Canada four years after FDA approval, and will accelerate its advance into the North American market, which accounts for more than half of the global epilepsy market."
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- ADHD drug Strattera discontinues supply in Korea
- by Kim, Jin-Gu Jun 19, 2023 06:00am
- Pic of Strattera The domestic supply of the ADHD (Attention-Deficit·Hyperactivity Disorder) treatment ‘Strattera (atomoxetine) was completely discontinued in Korea. Its supplier Lilly Korea said, “We have currently discontinued its supply, with no plans for resupply. According to the pharmaceutical industry on the 17th, Lilly Korea recently notified Boryeong Pharmaceutical that it will suspend the supply of Strattera. Lilly Korea has been supplying Strattera to the domestic market through Boryeong. Lilly Korea had notified Boryung about the discontinuation earlier this year and additionally announced that it has no plans to resupply Strattera in Korea. “Supply of Straterra will be discontinued not only in Korea but also in most countries," and "We have no plan to resupply the drug in Korea either." Regarding whether the company will voluntarily withdraw the drug’s authorization in Korea, it said, “We are currently discussing the specifics on withdrawing Straterra’s approval." Lilly Korea received approval for Straterra in Korea in 2006. Since then, the drug had led Korea’s ADHD treatment market with Janssen Korea’s Concerta OROS (methylphenidate). However, the gap between its sales and Concerta OROS had widened greatly recently. According to the market research instruction IQIVIA, the size of Korea’s ADHD treatment market was KRW 36 billion. Among those, Concerta OROS sold KRW 23.9 billion, and Straterra KRW 4.4 billion. In terms of market share, Concerta OROS has a monopoly over the market, occupying 67% of the market. Even in Q1 this year, there was a more than fourfold difference in sales between Concerta OROS’s KRW 6.9 billion and Straterra’s KRW 1.6 billion. Quarterly ADHD treatment market size (Unit: KRW 100 million, Data: IQVIA) Due to the prolonged monopoly of Concerta OROS, many competitors in addition to Lilly, whose headquarter discontinued the global supply of the drug, have discontinued the supply of its products or voluntarily withdrew their marketing authorizations in Korea 7 out of 15 domestically approved ADHD treatments have been withdrawn from the market. Hwanin Pharm's Metadate CD, Korean Drug’s Atomottera, Hanmi Pharmaceutical’s Atocera, Mundipharma Korea's Bisphentin, and JinYang Pharm's Amoxetine were withdrawn from the market either voluntarily or due to license expiry. Korea Pharma’s Domotin and Myungmoon Pharmaceutical’s Artrex are not being supplied to the market. Here, the supply of Lilly’s Straterra in Korea will also be discontinued. Boryung, which is in charge of marketing Lilly’s Straterra in Korea expects the discontinuation to not lead to a gap in the company’s performance due to its small sales volume. An official from Boryung said, "We are expanding our pipeline by introducing items in the overall CNS area, including ADHD while developing IMDs and generics. Discontinuing Straterra will not be a serious issue.”
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- Epkinly designated as an orphan drug in Korea
- by Eo, Yun-Ho Jun 19, 2023 06:00am
- Epkinly, the first bispecific antibody drug involving T cells, has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced that it designated AbbVie's lymphoma treatment Epkinly as an orphan drug. The specific indication is relapsed or refractory DLBCL with a history of two or more systemic therapies. Epkinly is a type of immunoglobulin 1 bispecific antibody that simultaneously binds to CD3 of T cells and CD20 of B cells and induces T cell-mediated killing of lymphoma B cells. Recently, the US FDA obtained approval through the rapid approval program, and the phase 1/2 EPCORE NHL-1 study became the basis for approval. The study enrolled 148 patients with CD20-positive diffuse large B-cell lymphoma, of which 86% were patients with unclassified diffuse large B-cell lymphoma, and 27% of these patients were DLBCL converted from indolent lymphoma. The remaining 14% were patients with advanced B-cell lymphoma. As a result, Epkinly showed an ORR of 61%, a CRR of 38%, and a median duration of response of 15.6 months in patients with relapsed or refractory DLBCL who had previously received an average of three treatments. In Korea, one type of B-cell lymphoma new drug, MONJUVI, was recently approved. MONJUVI, an introduced new drug from Handok, is used as combination therapy with Lenalidomide in adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not suitable for autologous hematopoietic stem cell transplantation and who have failed at least one previous treatment. MONJUVI binds to CD19, a B cell surface antigen protein, and has a mechanism of inducing B cell depletion by inducing direct apoptosis, antibody-dependent phagocytosis, and antibody-dependent cell-mediated cytotoxicity.
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- Forxiga generics occupy 20% of mkt 2 mths into their release
- by Kim, Jin-Gu Jun 19, 2023 05:59am
- Forxiga (left), Pic of Xigduo ‘Forxiga (dapagliflozin)’ generics have increased their market share to 20% within 2 months of entry into the market. With fierce competition unfolding in the prescription field, the total market size expanded to exceed KRW 10 billion per month. However, since so many products were released at the same time, the average monthly prescription amount per generic product amounted to only around KRW 20 million. According to the marker research institution UBIST on the 19th, the outpatient prescription amount of single-agent and combination dapagliflozin drugs was KRW 11 billion in May. The original drugs, Forxiga and Xigduo posted sales of KRW 8.8 billion, and the combined generics of the two products recorded KRW 2.2 billion. In terms of market share, the original drugs accounted for 79.9% and generics 20.1% of the market. This means that the market share of generic drugs has increased to 20% in just 2 months after entry. A large number of Forxiga·Xigduo generics were released after Forxiga’s substance patent expired in April. A total of 90 pharmaceutical companies obtained approval for 105 single-agent drugs and 64 combination drugs. By May, 60 single-agent drugs and 31 combination drugs were released. The total market size has also expanded to more than KRW 10 billion per month. In March, before the full-fledged addition of generics, the total market size was KRW 9.5 billion, but in May, the market increased by 15.2% in 2 months to KRW 11 billion. The analysis is that the introduction of generic products in droves and fierce sales competition at the prescription site led to the expansion of the overall market. Monthly prescription performance of Forxiga and Xigduo original and generic However, with so many products entering at the same time, the average profit made by the companies was minimal. In the case of single-agent drugs, 60 pharmaceutical companies recorded a total of KRW 1.44 billion in prescriptions in May. The average prescription amount for each generic drug is only around KRW 24 million. In the case of combination drugs, 31 pharmaceutical companies recorded KRW 772 million in prescriptions in the same month. The average prescription amount per combination product was around KRW 31 million. ▲Boryung Pharmaceutical’s Trudapa, and ▲Hanmi Pharmaceutical’s Dapalon among single-agent drugs, ▲ Boryung Pharmaceutical’s Trudapa M, ▲ Hanmi Pharmaceutical’s Dapalon Duo, and ▲Kyung Dong Pahrma’s Dapamet among combination drugs, posted over KRW 100 million in monthly sales each. Among 60 companies that released single--agent drugs, over half – 29 companies – earned less than KRW 10 million a month. In the case of combination drugs, 17 of the 31 companies recorded monthly sales of less than KRW 10 million. Sales of the original drug, Forxiga, which posted sales of KRW 5.2 billion in March, fell 9.7% in May. In the same period, Xigduo’s sales fell 5.0% from KRW 4.3 billion to KRW 4.1 billion. Forxiga and Xigduo’s prices did not fall despite the release of their generics. AstraZeneca filed a lawsuit against the government to cancel the drug price cut and requested suspension of execution of the government’s price cut disposition. The court accepted AstraZeneca's request for suspension of execution. Therefore, the original drug’s price will remain the same until February next year. The suspension of disposition decision is considered a success on AstraZeneca’s part as it succeeded in delaying the drug price cuts and did relatively well against the large number of generics that were introduced to the field.
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- Lipiodol is in stable supply despite price cuts
- by Nho, Byung Chul Jun 16, 2023 05:55am
- Guerbet Korea X-ray contrast agent Lipiodol Ultra (iodized oil), which caused controversy over supply and demand, faced a drug price cut due to the entry into a generic on the 1st of last month. Still, it is understood that the supply is stable so far. In the meantime, Guerbet Korea has been negotiating with the health authorities for reasons such as 'reduced margins due to price hikes for raw material drugs' and 'justice to maintain current drug prices due to application for price adjustment'. However, in 2020, Dongkook Pharm's Fattiodol, a competitive product with the nature of an alternative drug, obtained approval from the Ministry of Food and Drug Safety and was released, and the generic drug price calculation following patent expiration was applied from May 1 this year. Last year's sales of Lipiodol and Fattiodol according to drug distribution performance standards were about 2.8 billion won and 36 million won, respectively. According to industry estimates, Guerbet Korea did not take out the extreme card of refusal to supply because it cannot hand over the market to competing generics. Lipiodol, an old-drug original drug licensed in 1998, was sold at 52,560 won in June 2018, 190,000 won in August 2018, 189,224 won in January 2022, 133,000 won in September 2022, and 189,224 won in September 2022. It has experienced drug price increases and decreases seven times in the last five years, including 19,224 won, 133,000 won in 2023, and 101,745 won in May 2023. The price of Fattiodol 10·5ml was reduced twice: 113,050 won and 75,367 won in 2020 and 101,745 won and 67,830 won in 2023. Regarding this, Dongkuk Pharmaceutical said, "We plan to do our best to ensure a stable supply of Fattiodol from the patient's point of view. However, it is true that the cost rate of related drugs is so high that profitability is not good." It is a necessary part to reestablish the direction of rational drug price calculation.” Since cost disclosure is a corporate trade secret, it is difficult to ascertain the exact details. In addition, Guerbet Korea and Dongkuk Pharmaceutical's only way to raise or preserve drug prices is to apply for a drug price adjustment, but they cannot use it because there are alternative drugs for Lipiodol and Fattiodol. Because of this, both Guerbet Korea, the original company, and Dongkuk Pharmaceutical, the generic company, are bound by the institutional shackles of essential medicines and are forced to fall into the dilemma of continuous supply of drugs, which is their ethical duty as pharmaceutical companies. In the worst case, if two pharmaceutical companies stop supply at the same time because of lower margins due to drug price cuts, a supply-demand crisis is expected. On the other hand, Lipiodol's main ingredient is iodized fatty acid ethyl ester (iodized oil) derived from poppy seeds and is used for lymphography, salivary gland imaging, carotid artery chemoembolization for liver cancer, and hysterosalpingography.
- Company
- Ultomiris under review as myasthenia gravis Tx in Korea
- by Eo, Yun-Ho Jun 16, 2023 05:54am
- The paroxysmal nocturnal hemoglobinuria (PNH) treatment ‘Ultomiris’ is seeking to secure an indication for myasthenia gravis (gMC) in Korea. According to industry sources, AstraZeneca Korea submitted an application to the Ministry of Food and Drug Safety and is being reviewed for the indication to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor (AChR) antibody-positive. Ultomiris’s myasthenia gravis indication was approved by the US FDA in April 2022, and by the European Commission in September of the same year. Myasthenia gravis is a rare, chronic, autoimmune neuromuscular disease that causes patients to lose muscle function and cause severe weakness. AChR antibody-positive patients account for about 80% of all gMG patients. The approvals abroad and the application in Korea are based on the positive results of the Phase III CHAMPION-MG trial. In the trial, Ultromiris demonstrated superiority over the placebo in the 26-week change in MG-ADL(Myasthenia Gravis-Activities of Daily Living Profile) total score, a patient-reported symptom improvement scale used to measure the difficulty of everyday activities. The safety profile of ULTOMIRIS was comparable to placebo and consistent with that observed in Phase III trials of ULTOMIRIS in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The most common adverse reactions in patients receiving ULTOMIRIS were upper respiratory tract infection and diarrhea. Myasthenia gravis is a rare disease that affects about 5 people in 100,000 and can occur in people of all ages. In children and the elderly, symptoms of decreased muscle strength are caused by immune disorders. Systemic myasthenia gravis is an unpredictable chronic autoimmune disease, where the autoimmune antibodies that trigger the disease target specific proteins in the postsynaptic membrane and disrupt synaptic transmission in the neuromuscular junction. Due to the gravity of the disease, major countries have been actively granting accelerated review and orphan drug designations to candidate drugs. In the field, Argenx’s efgartigimod received US FDA approval. Johnson & Johnson’s nipocalimab is also nearing commercialization. Also, Immunovant has completed the Phase III trial for batoclimab, for which it had signed a license transfer agreement with the Korean company Hanall Biopharma.
