New York Times: F.D.A. Panel Declines to Endorse Controversial Alzheimer’s Drug
The Alzheimer’s drug, aducanumab, made by Biogen, would have been the first new Alzheimer’s drug in two decades, but a panel from the Food and Drug Administration recently rejected its effectiveness, suggesting that the evidence was not persuasive enough, and did not show enough effectiveness in slowing cognitive decline. Ten out of 11 panel members voted that it was not “reasonable” to consider the research presented as “primary evidence of effectiveness of aducanumab for the treatment of Alzheimer’s disease.” The clinical trials for this drug only had one out of two Phase 3 trials show positive results, and those results only appeared when analysis was done on additional data after the trials have been stopped. Nearly six million people in the United States and around 30 million people around the world have Alzheimer’s disease. Aducanumab was supposed to be given as a monthly intravenous infusion and would cost about $50,000 per year; it would have been the first medication to address cognitive decline by attacking the core biology of the disease. For more information on the new drug, click here. For more information on the detrimental effects of Alzheimer’s disease, click here.