FDA Approves Controversial New Alzheimer’s Drug

The drug, also known as Aduhelm, received “accelerated approval,” which means Biogen is required to conduct “post-approval studies” to confirm the treatments have the clinical benefits they claim. If these studies, known as Phase 4 confirmatory trials, don’t fail to do so, the FDA could remove the drug from the market. In addition to the benefits of the drug being under scrutiny, so is the price, which wholesales for $4,312 per infusion, or $56k/year.