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- 2025-12-26 08:56:52
- Company
- Ipsen established a union led by MZ generation
- by Jul 05, 2021 05:54am
- A labor union led by MZ generation (1980-2000s) is also being established in the pharmaceutical industry. According to the pharmaceutical industry on the 2nd, a labor union consisting of Ipsen sales workers officially launched on the 2nd after reporting on the 29th of last month. The union leader is Choi Chang-woo (35 years old), a young employee who has been employed for three years. "It was established to improve the unreasonable and closed company policy implemented by senior managers," he explained. "Ipsen Korea is using sexual harassment, harassment at work, violations of the Labor Standards Act, power abuse, and disadvantages to certain employees," the union said in a statement. "We are creating working conditions and corporate culture that are inconsistent with Ipsen Global." The labor union set the goal of ▲ establishing labor's three primary rights ▲ democratization of corporate management and establishing fairness and transparency in performance distribution ▲ improving working conditions equivalent to multinational pharmaceutical companies. "The top priority is to normalize Ipsen Korea, which is operating abnormally," Chairman Choi said. "We will gradually increase the number of union members to form a majority union."
- Company
- Metformin with excess NDMA was removed from the market
- by An, Kyung-Jin Jul 03, 2021 05:56am
- Most of the prescriptions for 31 types of Metformin, which had been suspended for detection of excess impurities a year ago, have disappeared. Sales of drugs, including Metformin, rose, but some companies were virtually kicked out from the market. There are many opinions that the government should take a more careful suspension of sales. According to the drug research agency UBIST on the 1st, JW Pharm's Guardmet had no outpatient prescription until May this year. It posted ₩4.2 billion in prescription performance during the same period last year, but has not sold since June. Guardmet is a combination of JW Pharma's DPP-4 inhibitor Guardlet(Anagliptin) and Metformin. Although it emerged as JW Pharma's main product as prescription performance rose sharply to ₩5.6 billion in 2017, ₩8.2 billion in 2018, and ₩9.7 billion in 2019, all three doses, including "Guardmet" 100/500mg, 100/850mg, and 100/1000mg, disappeared from the prescription market in May last year. Sales amounting to ₩10 billion a year have been lost due to unexpected detection of impurities. In the case of Hanall's Glucodaun OR, the company posted a cumulative sales of ₩3.3 billion from January to May last year, but no sales this year. Glucodaun OR has been temporarily suspended. It recorded ₩8 billion in accumulated prescriptions in 2019. The MFDS said on May 26 last year that it has temporarily suspended manufacturing and sales and imposed prescription restrictions as 31 items were found to contain excess carcinogenic N-nitrosodimethylamine (NDMA). It has been about six months since the risk of impurities erupted in Singapore. Singapore's Health and Science Administration (HSA) recalled three products in December 2019 on the grounds that more than NDMA was detected as a result of investigating 46 items of Metformin on sale locally. The MFDS is applying the maximum daily allowance of based on NDMA 96ng provisional management standards. 31 items from 22 companies, which were suspended from sale at the time, accumulated ₩10.3 billion in five months from January to May last year, but only ₩800 million this year. It is down 91.8% year-on-year. There were no sales of 25 items except for Jeil's Lipito-M, HKinno.N's Atomet SR and Daewoong Bio's Diformin XR. Products from 19 companies, including JW Pharm, Hanall and Jinyang, have virtually left the market after the impurity measures. Several companies have induced prescription changes to other drugs or similar products of their own that have not been suspended from sale. For example, Daewoong Bio's "Diaformin" made a prescription record of ₩25 million for five months this year. Although the three capacities, Diformin XR 500 mg, Diformin XR 750 mg and Diformin XR 1000 mg, were suspended for NDMA provisional over-detection, Diformin 250 mg, Diformin 500 mg and Diformin 1000 mg products were available for sale. However, compared to ₩546 million in the same period last year, the amount of prescriptions decreased 62.5% in a year. In the case of Lipito-M and Atomet, only some of them were suspended, recording prescription results of more than ₩300 million and ₩100 million, respectively, this year. Except for JW Pharma and Hanall, of course, the rest of the companies are not losing much. Of the 31 items, Hutecs' Gluless-M and Nelson's Glutamin, which were among the top prescriptions, managed to exceed ₩200 million in cumulative prescriptions by May last year. During the same period, Hanmi's Grimefol SR, Shin Poong's Dybis and Unimaryl M have less than ₩200 million in prescriptions. The prescription loss is only less than ₩1 billion. Metformin had little influence on the entire pharmaceutical market. Last year, the prescription amount of a single metformin drug was ₩77.3 billion, up 4.1% from the previous year. Considering that it increased 2.9% year-on-year in 2019, the increase was even greater. Last year, the amount of prescriptions for Metformin combined with DPP-4 inhibitors was ₩458.4 billion, up 10.5% from the previous year. Similarly, it rose 8.2% year-on-year. Despite the spread of COVID-19 infections and the detection of impurities, there was little damage to the prescription market. The reason is that discontinued products account for a small percentage of the product and that there is no drug to replace Metformin that can be prescribed for type 2 diabetics. It is diagnosed that some of the learning effects of the high blood pressure treatment Valsartan, Ranitidine, and Nizatidine have been shown to have minimal harmful effects. However, some say that the MFDS should be more careful in taking measures related to impurities. The MFDS suspended the sale of the entire product if even one lot number of NDMA excess raw material was found for Metformin agents. They say they will allow sales if the problematic product is recovered and proven suitable for carcinogens by lot numbers. However, it has been a year since the temporary suspension of sales, but it is confirmed that no companies have attempted to sell them. Due to the characteristics of generics, it is recognized that it will be kicked out of the market once it is suspended. They say that the unexpected detection of impurities and suspension of sales during manufacturing process are damaging pharmaceutical companies. An official from the pharmaceutical industry said, "In the U.S., in the case of Valsartan and Ranitidine, only the lot numbers that used impurities detection raw materials were recovered. they did not suspend sales of the entire item," He said. "We need to be more careful about temporary sales suspension measures due to the detection of impurities."
- Company
- Lilly applies for listing of its fast-acting insulin Lyumjev
- by Eo, Yun-Ho Jul 03, 2021 05:56am
- The reimbursement benefit listing process for Lilly’s fast-acting insulin ‘Lyumjev’ will begin. According to industry sources, Lilly Korea had recently applied for the reimbursement of Lyumjev (insulin lispro). The drug, which has been approved in Korea on the 28th of last month, is attempting quicker market entry using the Drug Approval – Benefit Evaluation Linkage System. Lyumjev is a mealtime insulin that contains the fast-acting active ingredient, ‘insulin lispro’ which helps patients with Type 1 and Type 2 diabetes control their high blood sugar levels after meals or maintain their blood sugar in the target range. The domestic approval of Lyumjev was based on the results of the PRONTO clinical trial program that was conducted on adult patients with Type 1 and Type 2 diabetes. The PRONTO-T1D and PRONTO-T2D trials evaluated the safety and efficacy of Lyumjev compared to Humalog in people with type 1 and type 2 diabetes, respectively. The studies were designed as treat-to-target trials in which each arm was treated to achieve the same level of blood glucose control and evaluated for other important treatment effects, such as rates of hypoglycemia and post-meal glucose control, as well as maintenance of appropriate blood sugar levels. Results from both studies showed that Lyumjev was found to be non-inferior to Lilly’s existing fast-acting insulin ‘Humalog (insulin lispro) with regard to HbA1c reduction from baseline to week 26 (primary endpoint) when administered after meals. Also, Lyumjev demonstrated a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Results of Phase 1 clinical trial on Type 1 diabetes patients had also shown that Lyumjev is absorbed faster than ‘Humalog,’ ‘insulin aspart’ and ‘fast-acting insulin aspart.’ Also, blood glucose excursions over the first 3 hours after administration of Lyumjev were comparable to those in participants without diabetes.
- Company
- Takeda's Susoctocog alfa has been designated as a rare drug
- by Jul 03, 2021 05:56am
- Korea Takeda's "Susoctocog alfa," a bleeding treatment for patients with acquired haemophilia A, was designated as a rare drug by the MFDS on the 1st. Hemophilia is a major hemorrhagic disease caused by a lack of clotting factors in the blood due to mutations in genes located on the X chromosome. Hemophilia A, caused by lack of coagulation factors, accounts for about 70% of all hemophilia patients. Among them, acquired hemophilia A is an autoimmune antibody to coagulation factor VIII, which is a very rare condition in which coagulation factor VIII in the blood is suppressed and depleted, resulting in bleeding-related complications. It is reported that 0.2 to 1.48 out of 1 million people occur per year. Unlike congenital haemophilia, which usually occurs in boys, most of them appear at a similar rate for both men and women aged 65 and older. Kim Na-kyung, general manager of Takeda's Hematology BU, said, "We are pleased that the designation of rare drugs will help patients with acquired hematology A more stable treatment of the disease.""We will not only research and develop innovative treatments to positively change the lives of patients with rare hematopoietic diseases, including patients with acquired hemophilia A, but also do our best to improve the treatment environment." Rare drugs are treatments used for diseases with a population of less than 20,000 patients in Korea, meaning drugs that are used for diseases without proper treatment methods and medicines, or that have significantly improved safety or effectiveness than existing alternative drugs.
- Company
- Martín Corcoll, Boehringer Ingelheim Korea's new GM
- by Jul 03, 2021 05:56am
- Boehringer Ingelheim Korea announced the appointment of Martín Corcoll as the company’s new GM and Head of Human Pharm as of July 1st. Since joining Boehringer Ingelheim in 2006, the new GM Corcoll had accumulated extensive experience and expertise in the industry, serving in various positions and divisions for over 15 years. After graduating from the University of San Andrés in Argentina with a Bachelor’s degree in Business Administration, he obtained an MBA from ESADE Ramon Business & Law School in Barcelona, Spain. In 2006, Corcoll joined Boehringer Ingelheim Mexico as a central nervous system (CNS) and urology brand manager. After establishing a solid foothold as a cardiovascular marketing leader until February 2010, Corcoll moved on to the Boehringer Ingelheim's headquarters in Germany as a global brand manager of the company’s diabetes division. During his time in Germany, Corcoll was recognized for his expertise and successful contribution to the company’s growth in establishing international alliances for its diabetes division and leading the global launch of the company’s diabetes products. Until 2018, Corcoll served as the Marketing Head of Human Pharma at Boehringer Ingelheim Spain and oversaw the primary care and specialty care brands, after which he moved to the Austrian branch to serve as the Regional Business Manager and as became the Head of Human Pharma and GM of Boehringer Ingelheim Austria in 2019. “I am pleased to be joining Boehringer Ingelheim Korea. I had a great interest in our Korean branch as I often heard of the performance and growth it has made during my time in Boehringer Ingelheim.” said Corcoll. “Based on the company’s corporate vision, ‘create value through innovation,’ the company will strive to improve the health of our patients and animals in Korea by providing effective new drugs and healthcare solutions for diseases with a high unmet need.”
- Company
- Opdivo+Yervoy's negotiations failed to reach an agreement
- by Jul 01, 2021 05:56am
- Drugs for the combination of the immuno-cancer drugs Opidivo (Nivolumab) and Yervoy (Ipilimumab) in primary treatment for kidney cancer were not negotiated within days. In the end, it is expected to take longer to apply the benefit. According to related industries on the 1st, Ono Pharmaceutical and BMS have extended drug price negotiations with the NHIS for Opdivo and Yervoy kidney cancer primary treatment benefits. Earlier, Opdivo and Yervoy combination therapy was recognized for their benefit adequacy and began drug negotiations with the NHIS for "median or high-risk progressive neocyte cancer treatment" at the HIRA. Pharmaceutical price negotiations run for up to 60 days, and the recent period has expired. The NHIS and pharmaceutical companies never reached an agreement. However, they decided to extend it because they believed that additional negotiations were needed. PD-1 inhibitor immuno-cancer drugs Opdivo and CTLA-4 inhibitor immuno-cancer drugs Yervoy demonstrated excellent effectiveness in primary treatment of kidney cancer. In June 2020, and it passed the HIRA's Cancer Drugs Benefit Appraisal Committee. Later, it took about nine more months for the HIRA's Pharmaceutical Benefits Advisory Committee to recognize the benefit adequacy. In clinical trials of CheckMate-214 compared to the standard treatment of Sutene (Sunitinib Malate) in intermediate and high risk groups, Opdivo and Yervoy combined therapy showed a significant effect compared to the median (mOS) of 48.1 months, compared to 26.6 months. The objective response rate was also significantly higher at 41.9% to 26.8% and the rate of patients maintaining it was higher (65.2% to 49.6%). In particular, 10.4% of patients treated with combination therapy reached full response and received attention. Professor Park Soo-hyung of Kaist GMSE said, "In immune mechanism, CTLA-4 activates priming, which is the first antigen-specific immune response, to induce T-cell reactions, and anti-PD-1 prevents degradation of T-cells, which can create synergies." If Opdivo and Yervoy therapy are listed, the use of immunocancer drugs in kidney cancer is expected to become more active. This is also the first case in which immuno-cancer drug combination therapy is applied in chemotherapy. Both companies are also seeking to expand insurance coverage for Opdivo and Yervoy combined therapy in primary care for non-small cell lung cancer.
- Company
- Yuhan’s Leclaza reimb. held back by companion diagnostics
- by Eo, Yun-Ho Jul 01, 2021 05:56am
- Reimbursement of the novel domestic drug ‘Leclaza’ that was due today (July 1st) was postponed. The listing process of Yuhan Corporation’s new drug which had been progressing at an unprecedented pace came to a full stop due to ‘companion diagnostics.’ Dailypharm found that the Ministry of Health and Welfare had pulled a temporary stop on the enforcement of the notice related to Leclaza (lazertinib). Leclaza was supposed to be listed from July after passing the Health Insurance Policy Deliberative Committee’s review on the 25th of last month. The brakes were pulled by an objection that was registered during the pre-announcement of administration period regarding the lack of a companion diagnostics device Delayed listing of a drug that has already passed the HIPDC deliberations is rare. Since 2018, the Ministry of Food and Drug Safety had regularized a sort of ‘customized use’ of in-vitro companion diagnostics devices through the ‘Guideline on the Review & Approval of companion diagnostic medical devices,’ under which a drug and the companion diagnostics device used as the basis for medications and prescriptions are reflected together in the license. The measure was implemented to precisely screen patients eligible for each prescribed drug target. The problem was that no MFDS-approved diagnostic device existed for the purpose of prescribing Leclaza even though the drug already passed the HIPDC review. Under the current regulations, 3rd generation EGFR TKIs like ‘Tagrisso (Osimertinib)’ and Leclaza may only be prescribed to ‘patients whose EGFR T790M mutation status has been confirmed with an in-vitro diagnostic medical device approved by MFDS.’ In-vitro diagnostic medical devices that are approved and used to identify the EGFR T790M mutation status in Korea include the blood-based ‘Cobas EGFR Mutation Test,’ and ‘PANAMutyper EGFR Kit,’ among others. However, these devices are only approved to be used to screen patients for Tagrisso. In other words, the objection was that Leclaza prescriptions, if made, are all off-label prescriptions, and therefore unfit for reimbursement. As the health authorities have been limiting reimbursement of anticancer therapies with targets such as Tagrisso, the immunotherapy ‘Keytruda (pembrolizumab).’ ‘Tecentriq (atezolizumab),’ the ALK-inhibitor ‘Xalkori (crizotinib), and 'Alubrig (brigatinib)' to those that have used approved diagnostic devices to prescribe the therapies, it was difficult for the government to overlook the objections made regarding this matter. Accordingly, the MFDS had requested the Ministry of Food and Drug Safety to deliberate on whether the in-vitro diagnostic device needed for the prescription of Leclaza should be regarded as a 'companion diagnostics device.' To add an in-vitro companion diagnostic device to a drug's license, additional data that demonstrates that the diagnostic device used in the clinical trial and the device the company wishes to register is equivalent in identifying EGFR T790M mutations need to be submitted. Generally, it takes around 3 to 4 months for the tests to be conducted and the MFDS license to be updated.
- Company
- Hanmi’s Efpeglenatide reduces cardiovascular risk
- by Chon, Seung-Hyun Jul 01, 2021 05:55am
- Sanofi announced a study that reduces the risk of cardiovascular and kidney disease of new diabetes drugs that have returned rights to Hanmi. Hanmi plans to find new opportunities based on research results. According to Hanmi on the 29th, Sanofi held an independent session for Efpeglenatide at the American Diabetes Association (ADA) and announced the results of AMPLITUDE-O on eight subjects through eight researchers for two hours. Efpeglenatide is a GLP-1 family of diabetes drugs that Hanmi transferred technology to Sanofi in November 2015. It is a new bio-drug that extends daily injections from once a week to up to once a month. Sanofi conducts five clinical trials of Efpeglenatide. It finally gave back its rights to Hanmi in September last year. The findings released by Sanofi this time were conducted on more than 4,000 patients, the most among five clinical trials. AMPLITUDE-O Phase 3 clinical trials were given weekly Efpeglenatide or placebo to 4,076 patients with type 2 diabetes or cardiovascular disease in 344 regions in 28 countries. In type 2 diabetes patients, the risk of cardiovascular and kidney disease was significantly reduced when administered in two doses, Efpeglenatide 4mg and Efpeglenatide 6mg. The incidence of major cardiovascular diseases in the Efpeglenatide group compared to the placebo group decreased statistically to 27% and 32% in kidney disease. Professor Naveed Sattar of the University of Glasgow said, "The AMPLITUDE-O clinical trial safely reduced the incidence of major cardiovascular and kidney disease in low-risk and high-risk patients with type 2 diabetes." Major speakers and topics of the independent session for Efpeglenatide conducted by Sanofi (data: Hanmi) "Efpeglenatide has prepared a new opportunity to create another innovation," said Baek Seung-jae, executive vice president of Hanmi Pharmaceutical. "We are focusing our company's capabilities on expanding and materializing the potential of Efpeglenatide, which has been proven through large-scale global clinical trials," he expected. Another global clinical phase 3 (AMPLITUDE-M) result of Efpeglenatide, which was conducted on 406 type 2 diabetes patients whose blood sugar is not controlled by diet and exercise, was also introduced by Dr. Juan Frias, a leading researcher. The clinical trial, which was conducted with double blindness, divided Efpeglenatide into three dose groups (2mg, 4mg, and 6mg) for 56 weeks, compared Glycated hemoglobin with primary evaluation variables for 30 weeks, weight loss, and safety for 56 weeks. Studies have confirmed excellent blood sugar control and weight loss effects when Efpeglenatide is administered to type 2 diabetes patients. Treatment also remained stable for long periods of time. Glycated hemoglobin showed statistically superior improvements in all doses over placebo in Week 30 of treatment. Shortly after the announcement, the New England Journal of Medicine (NEJM) published a paper on Efpeglenatide. "Cardiovascular safety is an important factor that doubles the global competitiveness of drugs in large-scale clinical trials, allowing us to create other innovations and business opportunities," said Kwon Se-chang, CEO of Hanmi Pharmaceutical. Main screen of the New England Journal of Medicine (NEJM) introduced Efpeglenatide (reference: Hanmi)
- Company
- Generics for Pradaxa, Xarelto & Brilinta will be released
- by Kim, Jin-Gu Jun 30, 2021 05:57am
- Material patents of Pradaxa and Xarelto expire in July and October this year, respectively. As a result, 8 generics for Pradaxa and 200 generic for Xarelto are expected to be released early in the second half of this year. In November, 25 generics for Brilinta will be released. Ahn-Gook's generic for Galvus is expected to be released within the year according to the Supreme Court ruling. ◆Generics for Pradaxa & Xarelto in July and October Xarelto and PradaxaAccording to the pharmaceutical industry on the 28th, a total of 82 pharmaceutical patents will expire in the second half of this year. What attracts the most attention is the expiration of the material patent for two NOAC products. Material patent of Pradaxa expires immediately on the 17th of next month. Four companies received generic for exclusivity with a total of eight items. Ajou Pharm's Davitran, Intropharm's Davican, Jinyang Pharmaceutical's Pradabi and Huons' Hubitran can get the exclusivity to sell generics for nine months from July 18 to April 17 next year. Material patent of Xarelto expires in October. 23 companies such as SK Chemical, Chong Kun Dang, and Hanmi have avoided follow-up patents. Two of them received generic for exclusivity. SK Chemical's SK Rivaroxaban 2.5mg and Hanmi Pharmaceutical's Riroxban 2.5mg will be sold exclusively from October 4th to July 3rd next year. 62 companies have been licensed for 195 items. More than 200 generics are expected to be released after October 4, when material patents expire. The early launch of generics for Pradaxa and Xarelto contrasts with the withdrawal of Eliquis' generic market. Earlier, six to seven companies, including Chong Kun Dang, won the first trial on material patent of Elyquis. Thus, it has released generic early since June 2019. They have accumulated more than ₩10 billion in prescription performance through the first quarter of this year. In April this year, however, the Supreme Court sided with the original company, BMS. Generics voluntarily withdrew their products from the market. The early launch of generis of Pradaxa and Xarelto is expected to lead to a reorganization of the NOAC market. In the case of the two items, judgment of the decision to avoid the follow-up patent has been confirmed. As of last year, Pradaxa had ₩14.3 billion and Xarelto had ₩50 billion in outpatient prescription performance. Considering that generic for Eliquis has previously increased its market share around Clinics, generics for Pradaxa and Xarelto are also expected to be in the market. ◆25 generics for Brillinta are expected to be launched simultaneously after November The patent for the anti-platelet drug Brilinta expires in November. It is predicted that 25 generics will be launched at the same time as the patent expires. 25 items, including Boryung Ticagrelor by Boryung from November 21 this year to August 20 next year have acquired generic for exclusivity. Attention is also focusing on whether Ahn-Gook will be able to release Novartis' GPP-4 inhibitor family of diabetes drugs early on. The generic for exclusivity for generic for Galvus is the sole acquisition of Ann-Gook. The period is from 30 August to 29 May next year. In 2019, Ahn-Gook succeeded in invalidating some of the extended periods of material patents for the first time in Korea. As a result, it succeeded in pushing forward the expiration of material patent of Galvus, which was originally scheduled to expire in March next year, by about six months (187 days). However, Novartis appealed, and the Patent Court ruled that 55 days were invalid, not 187 days. The release date of generic for Galvus will be pushed back to January next year. The case now awaits the Supreme Court's final ruling. The Supreme Court's decision determines the timing of Ahn-Gook's generic for Galvus. If it accepts the judgment of the Patent Tribunal, it can be released in August. If the patent court accepts the ruling, it is expected to be released in January next year. If it accepts Novartis' claim, it can only be released after March of next year.
- Company
- JW Pharma acquires domestic license for fostamatinib
- by Chon, Seung-Hyun Jun 30, 2021 05:56am
- On the 28th, JW Pharmaceutical Corporation announced that it has entered into a licensing agreement with Kissei Pharmaceutical Co., Ltd for the development and commercialization rights in Korea of fostamatinib, a thrombocytopenia treatment. Under the licensing agreement, JW Pharmaceutical may develop, obtain regulatory approval, and market fostamatinib in the domestic market. Fostamatinib was originally developed by Rigel Pharmaceuticals, Inc., and Kissei acquired exclusive development and commercialization rights for fostamatinib in Japan, China, Korea, and Taiwan from Rigel in 2018. Immune Thrombocytopenic Purpura (ITP) is a condition in which the body’s immune system attacks platelets, causing the platelet count to become lower than normal. Patients with ITP are easily bruised, bleed easily, and have difficulty stopping bleeding. In severe cases, it can lead to cerebral hemorrhage or upper gastrointestinal tract bleeding, and therefore is a rare blood condition with a high unmet need. Fostamatinib is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP in adult patients. Contrary to existing treatments that boost blood platelet production, this first-in-class drug suppresses the destruction of platelets by macrophages and suppresses platelet depletion. Fostamatinib was approved by the U.S. FDA in 2018 for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatment, and is sold under the name ‘Tavalisse.’ According to post hoc analysis results of Phase III clinical trial presented at the 2019 American Society of Hematology (ASH) Annual Meeting, the use of fostamatinib as second-line therapy after treatment with corticosteroid showed a high treatment response rate in patients who have been diagnosed within a year. Also, fostamatinib has less dietary interference and drug-drug interactions than other oral formulations and may be taken regardless of food intake or other medications. JW Pharmaceutical plans to receive the orphan drug designation for fostamatinib in Korea to expand treatment opportunities for adult patients with thrombocytopenia. An official from JW Pharmaceutical said, “The company was able to add a new drug for a rare disease in our lineup through the agreement. We will work to progress the domestic approval process without any delay to provide treatment for patients suffering from chronic ITP.”
