Today, 265 LEAD Coalition member organizations and allies sent a joint public comment letter to the U.S. Food and Drug Administration (FDA) regarding its review of the supplemental biologics license application for donanemab (BLA 761248) for the treatment of mild cognitive impairment and early dementia due to Alzheimer’s disease. The letter expresses full confidence in the FDA’s impartial, rigorous, and expert review based on the merits of the Phase 3 data. The letter also emphasizes the importance of treatments that delay progression to the next clinical stage of disease. Read the letter here.
