On January 20, 142 LEAD Coalition member organizations and allies wrote to urge the FDA to utilize its regulatory flexibility in rendering a decision on biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease. Should FDA approve the application, the letter also recommends that a post-marketing surveillance study (also known as a Phase IV or confirmatory trial) be conducted to provide additional information about aducanumab’s benefits, risks and best use. Read the letter here
LEAD Coalition urges FDA to apply regulatory flexibility in review of aducanumab
