Biogen has announced that it will cease the development and sale of Aduhelm, its controversial Alzheimer’s drug, marking the end of a significant chapter in the company’s history. The decision follows difficulties in obtaining standard regulatory approval and concerns that by the time Aduhelm received such approval, newer medicines would have already entered the market. Initially granted accelerated approval by the FDA in 2021, Aduhelm faced challenges, particularly after the U.S. Medicare health insurance program limited coverage for the drug, severely restricting its use. This led Biogen to abandon the commercialization of Aduhelm in 2022.
Biogen will now focus its efforts on the launch of another Alzheimer’s medicine, Leqembi, in collaboration with Japanese partner Eisai, along with two experimental treatments targeting the tau protein associated with Alzheimer’s disease. Leqembi has received significant attention as the first treatment to show a slowing of cognitive decline in early Alzheimer’s patients, receiving standard approval based on its ability to reduce amyloid markers and slow cognitive and functional decline.
The controversy surrounding Aduhelm’s approval, its initial high price, and the subsequent struggle to find its place in the market highlight the complexities and challenges in developing and commercializing treatments for Alzheimer’s disease. Despite this setback, Biogen’s shift in focus towards Leqembi and other promising treatments offers hope for advancements in Alzheimer’s therapy and care.