Sumary of FDA approves Aduhelm, first new Alzheimer’s disease treatment since 2003:
- The FDA today granted accelerated approval for Aduhelm, the first new treatment to be approved for Alzheimer disease since 2003..
- “As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”.
- The most common side effects associated with Aduhelm involved ARIA, headache, fall, diarrhea and confusion/delirium/altered mental status/disorientation..
- Late last year, the FDA Peripheral and Central Nervous System Drugs Advisory Committee met to discuss a Biologics License Application for Aduhelm..
- Under the accelerated approval, the FDA is requiring Biogen to perform a new randomized controlled trial to verify the drug clinical benefit..
- If that new trial fails to verify clinical benefit, the FDA “may initiate proceedings to withdraw approval of the drug,”…