GENE ONLINE|News &
Opinion
Blog

.

Зеркало официального сайта всегда доступно для входа на Мостбет, даже при ограничениях. Скачать Mostbet – это шаг к удобству и азартным развлечениям.

Если вы ищете место для увлекательных ставок, обратите внимание на Joycasino, где лучшие предложения для игроков ждут вас.
2020-11-07| Trials & Approvals

Biogen’s Alzheimer’s Drug Turned Down by Independent Panel

by Rajaneesh K. Gopinath
Share To

After receiving promising comments from the FDA staff only days ago, Biogen wouldn’t have expected the agency’s Peripheral and Central Nervous System Drugs Advisory Committee to reject its Alzheimer’s drug, aducanumab. The panel voted 8-1 (2 uncertain), claiming that the EMERGE trial does not provide strong evidence supporting aducanumab’s effectiveness for Alzheimer’s Disease treatment.

When asked if the PRIME trial data demonstrated the drug’s efficacy, the panel voted 0-7 (4 uncertain). However, 5 members from the panel said yes to the question, “Has the Applicant presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology?” while 6 panelists were uncertain. In light of all these discussions, 10 out of 11 members disagreed that the EMERGE trial data can be used as primary evidence of the effectiveness of aducanumab.

“Alzheimer’s treatment is a huge, urgent, unmet need,” said panelist Dr. Joel Perlmutter, of Washington University School of Medicine. “But if we approve something with data that is not strong, we have the risk of delaying good, effective treatments.”

Shares of Biogen (BIIB) were halted on Friday in advance of the meeting, but the panel’s verdict is expected to impact its stocks once the halt is removed. However, the stocks of Eisai dropped from $99.12 to $83 per share within minutes of the announcement.

“Biogen thanks the many patients and advocates who shared their personal thoughts and experience at today’s Advisory Committee meeting, reflecting the significant unmet need for a treatment for Alzheimer’s,” said Michel Vounatsos, CEO of Biogen in a statement. “We appreciated the opportunity to share our data with the Advisory Committee, and we will continue to work with the FDA as it completes its review of our application.”

If the FDA still approves the drug, aducanumab will become the first authorized drug to slow cognitive decline in patients and mark a milestone in Alzheimer’s Disease treatment in nearly 20 years. However, the panel’s rejection would be a strong deterrent, and most probably, Biogen would be asked to conduct another study to provide clear evidence for aducanumab’s effectiveness.

By Rajaneesh K. Gopinath, Ph.D.

Related Article: Biogen Stocks Rise Following FDA’s Inspiriting Comments on Alzheimer’s Drug, Aducanumab

References
  1. https://investors.biogen.com/news-releases/news-release-details/update-fda-advisory-committees-meeting-aducanumab-alzheimers

 

©www.geneonline.com All rights reserved. Collaborate with us: [email protected]
Related Post
Major Win – FDA Grants Fast Track Designation to Adicet Bio’s ADI-001 for Lupus Disease
2025-02-07
Easing the Mental Health Burden: How MDMA, Psilocybin, and Other Psychedelics May Open Doors for Treating PTSD, Addiction, and Autism
2025-01-28
Drug Promotion, Nonprescription Pathways, and Advanced Manufacturing: FDA’s Key Focus Areas in 2024 and What’s Next for 2025
2025-01-23
LATEST
What the PlayStation Network Outage Can Teach the Biotech Industry
2025-02-08
Lilly’s Omvoh’s Two-Year Journey Confirms Lasting Impact on Crohn’s Disease Treatment
2025-02-08
Novo Nordisk Bets Big on CagriSema With A Heavyweight Move Planned for 2026
2025-02-07
Major Win – FDA Grants Fast Track Designation to Adicet Bio’s ADI-001 for Lupus Disease
2025-02-07
First-of-its-Kind Diagnostic Aid Uses a Single Hair Strand to Detect Autism Risk in Babies
2025-02-06
Teladoc Dials Up Virtual Care with $70 Million Acquisition of Catapult
2025-02-06
Silicon Valley in the Crosshairs as EU Readies to Strike U.S. Big Tech
2025-02-06
EVENT
2025-02-19
Healthcare Conference Taipei 2025
Taipei, Taiwan
2025-03-17
BIO-Europe Spring 2025
Milan, Italy
2025-04-21
World Vaccine Congress Washington 2025
Washington, U.S.A
2025-04-21
World Vaccine Congress 2025
Washington, U.S.A
2025-04-25
AACR Annual Meeting 2025
Chicago, U.S.A
Scroll to Top