Dominari Holdings, Inc.

One gastroenterologist called the price of Rezdiffra "problematic." Madrigal Pharmaceuticals already has physicians singing from its hymn sheet. Shortly after the biotech won approval in metabolic dysfunction-associated steatohepatitis (MASH), most gastroenterologists said they were familiar with its drug and planning to trial the brand within six months of its launch. Spherix Global Insights captured the views in a survey that asked 81 gastroenterologists for their opinion on the liver disease drug and projected uptake of the brand post-launch. More than 80% of the doctors reported unaided awareness of Rezdiffra’s approval. Seventy percent of the respondents said they are at least moderately familiar with Rezdiffra, a significant increase over the awareness level one year ago. More than three-quarters of the gastroenterologists expect to trial the brand within six months of its launch. The gastroenterologists said more than one-third of the MASH patients they look after are eligible for the drug, a finding Spherix said further bolsters the chances of swift uptake and utilization.  Interest in Rezdiffra reflects the fact it is the first MASH treatment and evidence that it can improve liver scarring. One physician told Spherix it is “nice to have a daily oral pill to help reduce hepatosteatosis and possibly reverse liver damage,” while another gastroenterologist noted the “good safety profile.”  Spherix heard some dissenting voices, though. One respondent commented on some gastrointestinal side effects and efficacy data that suggest the drug will fail “a large number” of patients. Another person called the list price—$47,400—“problematic,” adding that “we will have to see what third-party payer barriers are thrown up to its use.” Madrigal said the “price reflects value as first-and-only therapy for NASH” when it won approval. The biotech pointed to best-in-class health economics and outcomes research data along with the experience of its team to contend it can handle the market access side of the launch. Madrigal is aiming to achieve 80% commercial coverage by the end of 2024 and quickly cut the time to fill prescriptions to 30 days.  The Rezdiffra launch will focus on around 14,000 specialists, including 6,000 “top treaters,” who care for the 315,000 MASH patients with moderate to advanced fibrosis. If Rezdiffra can stop those patients from progressing to cirrhosis, it could prove its value by preventing liver failure, transplants and deaths.

A Spherix report shows that the size of Velsipity’s user base after three months—with about a third of gastroenterologists surveyed already prescribing the drug—was comparable to Rinvoq’s at the same point in its own launch, while decently outstripping Zeposia’s first-three-months performance. In its first few months of U.S. availability, Pfizer’s Velsipity has already made a splash in the moderate to severe ulcerative colitis (UC) space, where it’s up against BMS’ Zeposia, a fellow S1P receptor modulator, as well as biologics including AbbVie’s Humira and Rinvoq, J&J’s Stelara, Takeda’s Entyvio and Eli Lilly’s Omvoh, the last two of which were approved within weeks of Velsipity last fall. But Pfizer will need to step up its game to continue warding off those competitors, according to a report from GlobalData. In the report, healthcare analyst Filippos Maniatis noted that Velsipity has a leg up over Humira and other biologics for UC treatment because of its oral administration. It’s also backed by a strong showing in clinical trials, in which Velsipity appeared to produce better efficacy over placebo than Zeposia did in its own studies. Even so, Pfizer will need to pay close attention to both its competition—and especially close rival Zeposia—and the needs of patients to carve out a lasting future in the UC treatment space, per GlobalData, especially as future challengers emerge from the pipeline to join an increasingly popular field. “The UC market has become highly competitive in recent years, and can be considered a very dynamic field, with multiple therapies receiving approvals for the treatment of UC. Ongoing unmet needs in the field as well as the healthcare burden of the disease highlight the need for the development of advanced therapies,” Maniatis said. “There is an anticipation that pipeline agents in development for UC will eventually be able to address the need for highly efficacious treatment alternatives should these agents receive approval.” Pfizer declined Fierce Pharma Marketing’s request for comment. Data recently compiled by Spherix Global Insights about Velsipity’s first three months on the U.S. market since its approval last October indicate the drug’s potential to overtake its competitors in the space. The Spherix report shows that the size of Velsipity’s user base after three months—with about a third of gastroenterologists surveyed already prescribing the drug—was comparable to Rinvoq’s at the same point in its own launch, while decently outstripping Zeposia’s first-three-months performance. And while doctors are still in the early days of prescribing Velsipity, Spherix suggested that its user base, estimated to be 1.1% of the market as of the February analysis, could more than double in the next six months, bringing its market share close to Zeposia’s 4.3%. They’ll both still trail the brand share of Entyvio, Humira, Stelara and Rinvoq, however, especially as S1Ps continue to rank low on doctors’ views of the safest and most effective mechanisms of action in UC treatments—though the physicians surveyed by Spherix did praise Velsipity’s oral administration as a major plus. “Use and manufacturer launch perceptions for Velsipity are outpacing those of its S1P predecessor at the same point in its launch. Pfizer has a leg up on BMS as a respected and known entity in gastroenterology as the pioneer in the development of oral assets in IBD,” Jim Hickey, head of Spherix’s gastroenterology franchise, said in a statement sent to Fierce Pharma Marketing. “Gastroenterologists clearly desire to have an efficacious oral in the pre-biologic space,” Hickey continued. “While prescribers show a strong affinity for Rinvoq, the product’s label limits first-line use, creating a real opportunity for Pfizer with Velsipity. However, for Pfizer to be truly successful they will need to overcome pre-existing S1P perceptions stemming from Zeposia.”

近日，外媒报道，在最新报告中，卫材预计阿尔茨海默症（AD）新药Leqembi（lecanemab）2026财年全球销售额可以达到2900亿日元（近20亿美元），到2032财年将增加至1.3万亿日元（88亿美元）。Leqembi是一种抗β淀粉样蛋白（Aβ）单克隆抗体，可以选择性中和并清除导致阿尔茨海默病神经病变的可溶且有毒性的Aβ聚集体，因此可能对AD病理过程产生积极影响并减缓疾病发展进程。2023年1月，FDA在加速审批途径下批准了Leqembi治疗AD的上市申请。不过，只有在轻度认知障碍或轻度痴呆阶段且在病理学上确认存在Aβ的AD患者中才能进行Leqembi治疗。同年7月，Leqembi的加速批准成功转为完全批准。卫材表示，到2026财年，全球将有39.8万名患者有资格接受Leqembi治疗。随着诊断速度的加快和Leqembi治疗路径的简化，到2032财年，这一数字将激增至332万。目前，卫材的目标是在2024财年第一季度将神经病学客户专家的数量增加约30%。该公司还计划与渤健加强合作，后者正在美国处理Leqembi商业关税。不过，Spherix最近的调查发现，很少有神经科医生认为，与其他历史AD治疗药物相比，Leqembi是一种重大医学进步。目前Leqembi的覆盖范围也明显不足，因为保险问题，2/5可以接受治疗的患者没有获得处方。此外，Leqembi需要在专科中心注射，但根据Sphreix的报告，3/5的患者在与神经科医生实践无关的场外注射中心接受治疗。卫材希望通过推出Leqembi的维持剂量和皮下制剂来扩大其阿尔茨海默病业务，这可能会使患者接受药物治疗的体验更简单。Copyright © 2024 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。↑长按识别二维码 / 扫码即可报名↑