Sumary of FDA Approves Controversial Alzheimer’s Drug:
- June 07, 2021 — Amid significant controversy, the FDA on Monday approved the drug aducanumab for the treatment of Alzheimer’s disease (AD), ignoring the recommendation by its own advisory panel to reject the drug..
- Aducanumab was fast-tracked for approval, a process reserved for drugs that provide a meaningful advantage over existing treatments for a serious or life-threatening illness..
- In a release, the FDA agency said if the drug fails to show clinical benefit in this trial it has the option to withdraw its approval..
- Aducanumab’s approval marks the first new treatment approved for Alzheimer since 2003 and is the first to target beta-amyloid, the hallmark pathology of the disease..
- pic.twitter.com/2oJIeMADog In November, the Peripheral and Central Nervous System Drugs Advisory Committee voted 8 to 1 against approving the drug because, based on clinical trial results, evidence of efficacy was not strong enough..
- The FDA noted that today’s approval was based on three separate double-blind, randomized studies representing 3,382 Alzheimer patients..
- Rocky Road The road to approval has been extremely rocky for aducanumab, an anti-amyloid-beta human monoclonal antibody, previously known as BIIB037..
- However, 1 year later, a majority of the members of the FDA’s advisory panel were against the drug’s approval….