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- 2025-12-23 19:10:43
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- Reimb progress of 2 NMOSD drugs receive attention in 2H
- by Eo, Yun-Ho Jun 28, 2023 05:52am
- Whether the two optic nerve sclerosis drugs that have remained non-reimbursed for a long time in Korea will be reimbursed this time is receiving attention. According to industry sources, discussions are ongoing to introduce the agenda on reimbursing the neuromyelitis optica spectrum disorder (NMOSD) indication of ’Soliris (eculizumab)’ and ‘Enspryng (satralizumab)’ to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in the second half of the year. Both drugs have been receiving reviews for a long time. After expanding its indication in the first half of 2021, Soliris submitted its application to reimburse the indication in the second half of 2022. However, due to their high price, their companies have had difficulty setting reimbursement standards and fiscal sharing plans. However, with recent progress made for the first-in-class drug, Soliris, expectations have been rising on its DREC review. In the case of the latecomer Enspryng, as its company expressed intentions to accept the weighted average price (WAP) as its alternative, Soliris’s reimbursement listing will play an important role in the rise of a treatment option for NMOSD in Korea. Soliris’s efficacy was confirmed through the PREVENT study, in which the drug demonstrated efficacy in preventing the risk of recurrence of NMOSD. The results that were presented at NEJM in 2019 showed that among patients with anti-AQP4 antibody-positive NMOSD, 98% of patients treated with Soliris were relapse-free at 48 weeks compared with the 63% who were treated with placebo. At Week 144, the relapse-free rate in the Soliris group was 96% vs 45% in the placebo group. Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-AQP4 antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of ENSPRYNG-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Company
- B-cell lymphoma drug Polivy applies for reimb again
- by Eo, Yun-Ho Jun 27, 2023 05:47am
- The B-cell lymphoma drug ‘Polivy’ is reattempting to receive reimbursement in Korea. This time, the company applied for Polivy’s reimbursement with a different indication. According to industry sources, Roche Korea submitted an application for the reimbursement of its Diffuse Large B-Cell Lymphoma (DLBCL) treatment Polivy (polatuzumab vedotin) as a first-line treatment to use in combination with rituximab+ cyclophosphamide, doxorubicin, prednisone, etc. Polivy had applied for reimbursement for its first indication, as a third-line treatment in combination with standard BR therapy (rituximab-cyclophosphamide), in 2021, but failed to pass review by the Cancer Disease Deliberation Committee. Therefore, whether its reattempt for reimbursement in the first-line will be successful this time remains to be seen. Its first-line indication was approved by the US FDA in April and in November in Korea last year. The indication expansion was based on the Phase III POLARIX trial. In the POLARIX trial, all patients were followed for over 24 months, and at a median follow-up of 28.2 months, the risk of disease progression, relapse or death was reduced by 27% with Polivy + R-CHP compared with R-CHOP alone. The most reported adverse events (≥30%) in patients using Polivy+R-CHP were peripheral neuropathy (52.9%), nausea (41.6%), neutropenia (38.4%), and diarrhea (30.8%). Diffuse large B-cell lymphoma is an aggressive type of hematological cancer and the most common form of non-Hodgkin's lymphoma. In Korea, the number of new patients diagnosed with DLBCL is estimated to be near 5,000 each year. As the most common form of non-Hodgkin lymphoma, DLBCL is an aggressive (fast-growing) type of lymphoma that requires immediate treatment. DLBCL is generally responsive to treatment as over half of the patients reach remission, however, 30% to 40% of the patients do not respond to the standard-of-care, R-CHOP or experience relapse after first-line treatment. Despite being a fatal disease where most patients experience relapse within 2 years, and the life expectancy is only 6 months after relapse, the area is known to lack effective treatment options.
- Company
- Boryung Lenvima passed the first hurdle of the patent challe
- by Kim, Jin-Gu Jun 26, 2023 05:53am
- Eisai’s liver cancer drug LenvimaBoryung succeeded in crossing the first hurdle in the patent challenge for Lenvima, a liver cancer treatment. If the remaining two patents are avoided or invalidated, the early generic release is expected to be faster. According to the pharmaceutical industry on the 23rd, the Intellectual Property Trial and Appeals Board sided with Boryeong in a recent trial to confirm the scope of rights for a crystalline form of Lenvima, which Boryeong recently filed against Eisai. Boryeong is single-handedly challenging Lenvima patents. In November of last year, it filed a simultaneous request for a negative right scope confirmation trial and an invalidation trial for three Lenvima patents. At the time, Daewoong Pharmaceutical joined the patent challenge, but soon voluntarily withdrew and left. Lenvima is protected by five patents. Substance patents expiring in April 2025, usage patents expiring in March 2028, crystalline form patents expiring in June 2028, formulation patents expiring in March 2031, and manufacturing method patents expiring in August 2035. Among them, the manufacturing method patent that expires in 2035 has been listed in the Ministry of Food and Drug Safety Patent List since Boryeong started a patent challenge. Boryung plans to release generics in time for substance patent expiration after avoiding or invalidating the rest of the patents except substance patents. Subsequently, registered manufacturing method patents must be overcome by Boryeong. However, in the case of this patent, it is analyzed that Boryeong can be avoided relatively easily by using a composition or salt different from the original. If Boryung succeeds in the remaining patent challenges and releases Lenvima generics early, the anticancer drug portfolio is expected to expand further. Boryeong is concentrating on the anticancer drug business after 2020. Boryung's main strategy is to acquire the domestic copyright for the original product and release the first generic by overcoming patents. Boryung announced plans to add 10 first-generic anticancer drugs by 2026 in its "five-year mid- to long-term plan" announced last year. In July of last year, Fulvet was approved as the first generic of AstraZeneca's breast cancer treatment Faslodex. In addition to Lenvima, ▲Ipsen's liver cancer treatment Cabometyx, ▲BMS' acute lymphocytic leukemia treatment Sprycel ▲Novatis' leukemia treatment Tasigna ▲Pfizer's breast cancer treatment Ibrance challenged patents. However, the patent challenge to Tasigna was voluntarily withdrawn when Boryeong stopped developing generics. In the case of Ibrance, it was defeated in the first trial and has appealed to the Patent Court. The challenge to Sprycel came one step closer to the early release of generics after the usage patent expired in March 2024 as Boryung succeeded in avoiding the crystalline form patent in June of last year. In the case of Cabometyx, although it lost in the first trial, it is analyzed that there is no problem with the early generic release strategy. Ipsen, the original company, voluntarily deleted all claims that were the target of the patent challenge after Boryeong's request for judgment. Boryeong lost in the trial, but in fact, it is in a situation where the patent is not infringed even if the generic is released before February 2032, when the patent expires. Lenvima is Eisai's liver cancer drug. It is used in the first-line treatment of liver cancer together with Nexavar and Tecentriq + Avastin. According to IQVIA, a pharmaceutical market research institute, Lenvima's sales last year were 13.6 billion won. It decreased by 14% compared to 15.8 billion won in 2021. In the first quarter of this year, it posted sales of 2.3 billion won.
- Company
- Entresto’s reimb for HFrEF is extended again
- by Eo, Yun-Ho Jun 26, 2023 05:53am
- The reimbursement standards for the heart failure treatment ‘Entresto’ has been extended once again. According to industry sources, the reimbursement standards for Entresto (sacubitril) will be revised starting next month (July) to cover its use in combination with standard therapy (beta blockers, aldosterone antagonist, etc.) in patients with chronic heart failure with reduced ejection fraction whose left ventricular ejection fraction (LVEF) is below 40%. This is an extension from the previous reimbursement standard that was limited to ‘patients who have been receiving stable dose for over 4 weeks,’ and also an additional extension in becoming a first-line therapy after last year when the drug’s reimbursement was extended to ‘patients who were hemodynamically stabilized after being hospitalized for acute decompensated heart failure and has not received ACE inhibitors or angiotensin II receptor blockers.’ In other words, Entresto can now be used in combination with other standard therapies in patients with an ejection fraction of 40% or less and is positioned at the same status as ACE inhibitors and angiotensin receptor blockers. Entresto’s efficacy in HFrEF was identified in the Phase III PIONEER-HF study. In the PIONEER-HF study, a significant reduction of NT-proBNP was identified from Week 1 of treatment, and the clinical efficacy of Entresto was consistent among various patient groups including patients newly diagnosed with heart failure and RASi-naïve patients. Also, the 12-week open-label extension results that were presented at JAMA Cardiology 2019 showed that Entresto demonstrated consistent treatment effect and safety at Week 12. The difference between the two treatment groups, such as readmission within 8 weeks, was not narrowed for 4 weeks, confirming the clinical necessity of the initial use of Entresto. Entresto is currently recommended as the standard-of-care in heart failure treatment guidelines in Korea and abroad. The European Society of Cardiology (ESC) and the American College of Cardiology (ACC) recommends Entresto as a first-line treatment option, and in January 2021, the 2021 update to the ACC Expert Consensus Decision Pathway amended the guidelines to recommend Entresto ahead of ARB or ACE inhibitors. Also, the ESC’s Heart Failure Guidelines that was updated in August 2021 emphasized a combined treatment strategy that simultaneously initiates the use of 4 essential drugs including ARNI-class drugs (Entresto) that reduce the risk of death from heart failure. Meanwhile, Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that directly works on the heart. It works on two hormonal pathways, to activate the NP nerve hormones that benefit the cardiovascular system while inhibiting RAAS which is harmful for the cardiovascular system.
- Company
- Xospata makes progress for reimb...up for DREC review
- by Eo, Yun-Ho Jun 23, 2023 05:45am
- The reimbursement review for the acute myeloid leukemia treatment Xospata is making way to overcome the existing restriction that limits the reimbursement to 4 cycles. According to industry sources, Xospata (gilteritinib), Astellas Korea’s new drug for patients with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation will be presented for review at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting on July 1st. The drug’s reimbursement application is seemingly making relatively quick progress after passing the Cancer Disease Deliberation Committee in May. However, since Xospata was waived the pharmacoeconomic evaluation process, the drug would also have to undergo drug pricing negotiations with the National Health Insurance Service for its reimbursement extensions as well. The drug is indicated as monotherapy for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation (FLT3mut+). However, only patients who received allogeneic hematopoietic stem cell transplantation are eligible for reimbursement, for up to 4 cycles. Other than the financial issues, there are no specific reasons to limit the number of administration cycles for Xospata. In the ADMIRAL trial, Xospata was used without limiting the treatment period, and the NCCN guidelines also issued a ‘Category 1’ recommendation for the drug without restricting its treatment period. The current best option to cure AML patients is hematopoietic stem cell transplantation, but this is accompanied by a high risk of recurrence, and transplantation is not an option for the large number of elderly AML patients that exist. Therefore, there is no suitable treatment alternative other than Xospata available for patients who cannot undergo hematopoietic stem cell transplantations, and these patients are still using the chemotherapy that was developed over 40 years ago due to ineligibility for reimbursement of Xospata. Xospata targets both types of FLT3 mutations, FLT3-ITD and FLT3-TKD, and may be self-administered at home as a single oral tablet once daily without frequent hospital visits. Also, Xostapa has demonstrated improved safety and efficacy compared with existing chemotherapy.
- Company
- IND of LegoChem Bio's ADC was approved by the FDA
- by Hwang, Jin-joon Jun 23, 2023 05:44am
- LegoChem Bioscience announced on the 22nd that it has received approval from the US Food and Drug Administration (FDA) for a phase 1/2 clinical trial plan (IND) for 'LCB84' targeting various solid cancers such as triple-negative breast cancer and colorectal cancer. It submitted a clinical trial protocol to the FDA in May and obtained plan approval within a month. This clinical trial will be conducted in the United States and Canada for about 300 patients with advanced solid cancer. The safety and tolerability of LCB84 monotherapy and immuno-oncology combination therapy will be evaluated. The phase 1 dose-escalation trial is conducted in up to eight institutions. The phase 2 clinical trial (Dose Expansion) is conducted in 20 institutions. LCB84 is ADC new drug candidate that targets the truncated TROP2 antigen specifically expressed in cancer cells. It is a drug that has improved safety and efficacy by applying LegoChem Bio's next-generation ADC platform technology. LegoChem Bio disclosed the efficacy of LCB84 on refractory cancer cells through the American Association for Cancer Research (AACR) last year and World ADC London this year. Refractory cancer cells are cancer cells that do not respond to competing drugs. LegoChem Bio also announced preclinical data showing that LCB84 did not show significant toxicity in TROP2-expressing normal cells. "The clinical entry of LCB84 is meaningful in that LegoChem Bio independently develops clinical trials in the field of ADC," said Kim Yong-joo, CEO of LegoChem Bio. CEO Kim Yong-joo added, "We will enter more than one pipeline into self-directed clinical development every year."
- Company
- Expansion of indications for Forxiga as a treatment for HFrE
- by Jung, Sae-Im Jun 23, 2023 05:43am
- AstraZeneca Korea announced on the 22nd that its SGLT-2 inhibitor Forxiga has additionally obtained indications for HFpEF and HFmrEF from the Ministry of Food and Drug Safety. The indication approved this time is to reduce the risk of death due to cardiovascular disease, hospitalization due to heart failure, and urgent hospital visits due to heart failure in NYHA class II-IV patients. This positions Forxiga as a treatment for patients with chronic heart failure across the entire ejection fraction range. This indication expansion is based on the DELIVER study. DELIVER is the largest clinical study of SGLT-2 inhibitors in heart failure patients with an LVEF of 40% or higher. 6263 patients with chronic heart failure with an LVEF of 40% or more, with or without type 2 diabetes, participated. This included patients with a history of type 2 diabetes, those who were hospitalized or discharged for heart failure, and those whose ejection fraction had improved to 40% or more at the time of study entry. As a result of the study, Forxiga reduced the risk of cardiovascular death or worsening of heart failure (unscheduled hospitalization and hospital visits due to heart failure) by 18% compared to the placebo group. The DAPA-HF study and the DAPA-CKD clinical trial for patients with chronic kidney disease confirmed a reduction in the risk of death as a secondary endpoint compared to a placebo. Forxiga had a 23% lower risk of worsening overall heart failure and cardiovascular death compared to placebo. The KCCQ standard symptom evaluation score improved by an average of 2.4 points more than the placebo group. Shim Il, executive director of AstraZeneca Korea's CVRM division, said, "Forxiga is the only SGLT-2 inhibitor that has all three indications for type 2 diabetes, chronic heart failure, and chronic kidney disease, and we will do our best to provide benefits to more patients." said.
- Company
- GO for patent litigation, NO for suspension of execution
- by Kim, Jin-Gu Jun 22, 2023 04:14pm
- Janssen Korea has decided not to file a lawsuit for canceling a drug price cut and a request for suspension of execution following the appeal in a patent dispute. It is interpreted as an intention to avoid controversy over the abuse of the suspension system related to the so-called 'Drug Price Reduction and Refund Act' that recently passed the National Assembly. Janssen Korea Opsumit Patent Dispute Appeal Decision. "We will not proceed with the lawsuit to cancel the drug price reduction" According to Janssen Korea on the 19th, the company decided to appeal to the Patent Court in a dispute with Samjin Pharmaceutical over the Opsumit composition patent. This dispute was sparked by Samjin's request for a passive trial to confirm the scope of rights to the Opsumit composition patent in May of last year. In April of this year, Samjin Pharmaceutical won the trial by obtaining a 'claim established' from the Intellectual Property Tribunal (1st trial). Samjin, which won the first trial, released Maciten as the first generic of Opsumit earlier this month. This product was also listed on the list at the same time. Opsumit's price is expected to drop by 30% with the generic drug's insurance coverage. Originally, a price cut was expected this month, but it is said that the drug price cut was delayed by one month of the opinion gathering period, and Janssen Korea has made an objection. Janssen Korea decided not to go through legal procedures to delay the drug price cut in addition to raising objections. It was decided not to file a lawsuit against the government to cancel the drug price cut and to suspend execution accordingly. Many original companies have actively utilized the judiciary's suspension system to delay drug price cuts. Among them, the most common form was prolonged patent disputes. As the final decision has yet to be made, the drug price cut is unfair, so it requested that the drug price cut be suspended until the court makes a ruling. The judiciary cited most of these applications for suspension of execution. Even if it lost in the second trial, the original company prolonged the dispute until the third trial with the same logic, and as a result, the original drug price was maintained for three to five years until the final decision of the Supreme Court. Criticism was raised that the suspension of execution was abused by some. It was criticized for abusing the suspension system, which has a very high quotation rate, to delay drug price cuts even though pharmaceutical companies know they will lose in the main lawsuit. In fact, the Ministry of Health and Welfare has won 100% of the main lawsuits that have been going on so far. When this situation was repeated, the Ministry of Health and Welfare promoted legislation of the so-called Drug Price Reduction and Refund Act. It is a law that contains the basis for recovering health insurance finances that were excessively paid during the suspension of execution after the final judgment. Controversy arose in the course of discussions in the National Assembly, but the government pushed ahead with legislation by adding a provision for refunds in case of opposition, and eventually, this law passed the National Assembly in April. In the case of Opsumit, according to the judgment of Janssen Korea, it was possible to file a lawsuit for canceling a drug price cut and apply for suspension of enforcement. This is because the Drug Price Reduction Refund Act will take effect in November. The law, which passed the National Assembly in April, was promulgated in May, and the effective date is November 20, six months after the date of promulgation. From the perspective of Janssen Korea, it was possible to make the same choice as AstraZeneca Korea recently maintained the drug price of Forxiga through administrative litigation and application for suspension of execution. Janssen Korea decided not to do this. Janssen Korea's decision is to accept the drug price cut for Opsumit, which is expected next month. An official from Janssen Korea said, "After much consideration, we decided against pursuing a separate legal action and accept the financial repercussions, in recognition of the Korean government's drug price system and the potential financial burden on our patients." An official from Janssen Korea explained, "That doesn't mean giving up the Opsumit patent." “We have decided to appeal to the Intellectual Property Trial and Appeal Board, which determined that Samjin Pharmaceutical’s generic products do not fall within the scope of the Opsumit patent, and we filled a lawsuit for revocation of the Patent Court’s decision.” he emphasized. "The application for provisional disposition for patent infringement has not yet been decided."
- Company
- Leclaza confirms brain metastasis benefits
- by Hwang, byoung-woo Jun 22, 2023 05:41am
- "I think this is a meaningful study in that the third-generation EGFR TKI treatment, such as Lazertinib, showed data related to brain metastasis, but clearly focused on the intracranial response to confirm the effect." When brain metastasis occurs in non-small cell lung cancer patients using 1st or 2nd generation EGFR TKI agents, most patients' condition deteriorates rapidly, and furthermore, in the case of T790M negative, options are limited. A new therapeutic basis has emerged. A domestic phase 2 study that confirmed the effect of Lazertinib, the third generation, on patients with brain metastasis after failure of the existing 1st or 2nd generation EGFR TKI drugs in EGFR mutated non-small cell lung cancer was presented as a poster at the American Society of Clinical Oncology Annual Meeting (ASCO) this year. Professor Hye-ryeon Kim and Professor Min-hee Hong of Sinchon Severance Hospital Cancer Hospital, who led the study, said in an interview with the Medical Times, "It is meaningful in terms of IIT related to Lazertinib." It will be helpful in terms of future patient care.” In this study, 40 EGFR-positive patients who showed brain metastases after using first- and second-generation treatments were enrolled. The primary objective is to evaluate the intracranial activity effect of Lexraza in patients with asymptomatic or mild brain metastases. Professor Kim said, "When treating lung cancer patients with EGFR mutations, there are many experiences of brain metastasis, patients with poor prognosis, and rapidly deteriorating." It is very important to control the progression of brain metastases in EGFR-positive patients in a situation where they cannot survive long despite treatment such as back,” he explained. "In this respect, it is important to have a treatment that passes the Blood-Brain Barrier or BBB well, and Leclaza has good permeability to brain metastasis in preclinical studies, so we decided to evaluate it in clinical trials," he said. In the actual study, patients who failed the existing treatment were divided according to the presence or absence of the T790M mutation. The primary evaluation index was the intracranial objective response rate (iORR), and the secondary evaluation index was the intracranial iPFS. Regarding this, Professor Hong explained, "In clinical trials of Osimertinib, ORR was confirmed, and the brain was separately analyzed in relation to CNS metastasis in it." Professor Hong emphasized, “It is meaningful in that it is the first time that the objective response rate within the two was confirmed as the primary evaluation index.” In particular, the fact that the number of T790M-negative patients in this study was 33 compared to the T790M-positive five patients is also an eye-catching factor. In fact, Lazertinib and Osimertinib can be reimbursed in the case of T790M-positive patients, but in the case of T790M-negative patients, treatment options that can be used for patients are limited. It is the view of the two professors that they have it. Professor Hong said, “When metastasis occurs in the CNS, existing treatments have poor cerebral vascular penetration due to pharmacological mechanisms, so brain metastasis proceeds. In this case, secondary mutations of the tumor itself do not occur easily.” It was concluded that therapies focused on the CNS were able to prevent the progression of brain metastasis to some extent.” The results of the study showed that the intracranial ORR of 38 evaluable patients was 55.3%, with 3 complete responses and 18 partial responses. There were only 5 T790M-positive patients, but 4 showed a partial response, recording an intracranial response rate of 80%. Of the 33 T790M-negative patients, 3 complete responses and 14 partial responses showed an objective response rate of 51.5%. The overall PFS and the PFS period in the T790M positive and negative groups were analyzed to be 15.2 months, 9.9 months, and 15.4 months, respectively. The duration of intracranial PFS was similar for T790M positive and negative at 15.2 months and 15.8 months, respectively. Professor Hong said, “The design of the study itself is directly connected to the clinical field, and Lazertinib is helpful in patients with brain metastasis, and many of them did not have T790.” It is a study that shows the CNS response well while doing it.” It is evaluated that based on this study, options that can be considered in the clinical field can be increased. The two professors also mentioned plans to increase permits based on the research results. Professor Kim said, "The clinical trial was started and the recruitment of patients was faster than planned, which means that there is a lot of unmet demand." I would like to add significance in that this is a study that focused on iORR as the primary evaluation index and confirmed it, as the passing treatment is helpful." "Standard treatment is shifting from first-line treatment to third-generation treatment, but there are still many patients using first- and second-generation drugs," he said. We plan to try to increase the permits,” he added.
- Company
- JAKi Civinqo completes pricing negotiations for reimb in KOR
- by Eo, Yun-Ho Jun 22, 2023 05:40am
- The atopic dermatitis treatment ‘Cibinqo’ may be listed for reimbursement in Korea from July. According to industry sources, Pfizer Korea completed the pricing negotiations for its new JAK1 inhibitor drug Cibinqo (abrocitinib) with the National Health Insurance Service. Drugs that pass the Health Insurance Policy Deliberative Committee (HIPDC) review can immediately receive reimbursement benefits. The company had suspended the reimbursement application process after Cibinqo passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Standard Subcommittee review, and resubmitted the application earlier this year after extending the scope of coverage to adults and adolescents aged 12 years or older. The new application passed DREC in March and started pricing negotiations thereafter. As a result, competition in the JAK inhibitor market for the treatment of atopic dermatitis will expand to become a three-way race in the near future. Lilly Korea’s ‘Olumiant (baricitinib),’ and ‘Abbvie’s ‘Rinvoq (upadacitinib)’ has already been receiving reimbursement for the atopic dermatitis indication since May, and Rinvoq’s reimbursement was extended to cover adolescents recently. Sanofi-Aventis Korea’s ‘Dupixent (dupilumab,)’ which is of a different class, has also added a pediatric-adolescent AD indication and received reimbursement. Cibinqo has already landed in tertiary hospitals including the Seoul National University Hospital, Seoul Asan Medical Center, Seoul St. Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as major medical institutions in Korea. Therefore, Cibinqo can jump in and attract prescriptions immediately upon reimbursement. Meanwhile, Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at week 12 and demonstrated improvement in itch relief 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy in patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved EASI-75 (improvement of at least 75% in lesion extent and severity) at week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group, 5% higher than the placebo group.
