Aducanumab approval：FDA's biggest mistake or CNS drugs' new era?
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Event IntroductionOn June 7th, the FDA announced the approval of Biogen's BLA for aducanumab to treat Alzheimer's disease (AD), under an Accelerated Approval pathway. Aducanumab, a high-affinity IgG1 monoclonal antibody drug that targets a conformational epitope found on beta amyloid plaques in the brain, is the first novel disease-modifying therapy for AD since 2003, when AbbVie’s memantine was approved. Aducanumab had a rather atypical journey to its approval. In March 2019, Biogen halted multiple phase II and phase III trials, citing a lack of efficacy and an unlikely probability in meeting their primary clinical endpoints. However, interim analysis for the phase III EMERGE trial showed that the high dose of aducanumab at 78 weeks had met its primary endpoint in significantly reducing clinical decline. Biogen filed for BLA with the FDA in 2020 using the Phase III study data demonstrating clearance of aggregated amyloid beta by aducanumab, and the reduction of the clinical decline in AD patients. Following the approval of aducanumab, Biogen (BIIB) shares went up 38.3% at closing, while shares of their strategic partner based in Japan, Eisai (4523.T), rose 56%. Analysts have projected annual sales of about $4.8 billion by 2026. However, the approval of aducanumab was not without controversy. During its approval process, in November 2020, an FDA advisory committee convened to review Biogen's phase III data, and 10 out 11 committee members voted that the evidence was not sufficient to approve the drug, while 1 remained uncertain. Following the approval, three committee members—Dr. Joel Perlmutter, professor of neurology at Washington University St. Louis, Dr. David Knopman, a clinical neurologist at the Mayo Clinic, and Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School—resigned, citing concerns over the FDA’s decision-making process for this drug. In this virtual fireside chat, we will discuss the circuitous journey of aducanumab's approval, and explore why CNS drugs are notoriously difficult to gain approval. We will discuss some potential reasons behind why many of the world's largest pharma companies (Sanofi, Johnson & Johnson, Amgen, AstraZeneca, and Merck) chose to divest away from neuroscience in recent years, and what does aducanumab's approval mean to the field of CNS drugs. Some of the questions we will cover:
What's behind the approval of Aducanumab? Why is it so difficult to find a cure for Alzheimer? Does amyloid beta really cause AD, or is it merely a result? What parallels are there between aducanumab and Serepta's eteplirsen, and why is it a problem when the loudest backers of the drug candidate are the patients and patient advocates? What does this mean for other AD anti-plaque drugs in the pipeline?
Would a "pay for performance" model be better for patients and for the industry as a whole?
Speakers and Moderators
Speakers:
Xianbo Zhou, PhD: https://www.linkedin.com/in/xianbo-zhou-7b33b76/
Sheng Feng, PhD: https://www.linkedin.com/in/sheng-feng-b3257841/
Lina Wang, PhD: https://www.linkedin.com/in/wanglinank/
Samuel Gandy, MD, PhD: https://www.mountsinai.org/profiles/samuel-e-gandy
Daniel Luo, PhD: https://www.linkedin.com/in/daniel-jie-luo/
Qinghong Yan, PhD: https://www.linkedin.com/in/qinghong-yan/
Leon TANG, PhD: https://www.linkedin.com/in/leontangnyc/
Topic：Aducanumab approval, the biggest mistake by FDA or the new era for CNS drugs?
Time：9-11PM of Saturday, June 19th; 北京时间6/20周日上午9-11点Time：zoom or Clubhouse
Registration link: https://www.eventbrite.com/e/159366279833 (或点击文末“阅读原文”)
Event CommitteeEvent lead: Qinghong Yan
Event organizers: Daniel Luo, Leon Tang, Ethan Xu, Qinghong Yan
Event logistics: Daniel Luo
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