Biogen has announced that it will stop manufacturing a controversial drug for Alzheimer’s disease.
Biogen, a pharmaceutical company, announced on Wednesday that they will no longer pursue the development and promotion of Aduhelm, a highly debated treatment for Alzheimer’s disease. The decision comes amidst conflicting data regarding its effectiveness.
In 2021, the FDA gave expedited approval to a drug that focuses on removing amyloid plaques in the brain, believed to play a role in the disease. This approval was dependent on Biogen conducting a subsequent study to verify that the benefits of the treatment outweigh any potential risks.
However, following an evaluation of its research and development endeavors, the corporation concluded that it would be more beneficial to focus on creating other potential medications and promoting Leqembi, an Alzheimer’s drug it collaborates on with Eisai, which received traditional FDA approval in the previous year.
“When seeking novel medications, a single innovation can serve as the catalyst for future drug developments,” stated Christopher A. Viehbacher, CEO and President of Biogen. “ADUHELM served as the game-changing discovery that paved the path for a new category of drugs and revitalized investments in the field.”
Though Aduhelm and Leqembi were praised for their advancements in treating Alzheimer’s, the results of their clinical trials revealed only slight advantages for patients, as well as potential risks such as brain bleeding and swelling.
Medicare offers restricted coverage for Alzheimer’s medications that have received accelerated approval, but this coverage is only available to patients who are part of a randomized clinical trial. However, there are currently no trials enrolling patients. The cost of both Aduhelm and Leqembi is over $25,000 per year, making it difficult for patients to access these drugs.
According to an FDA representative, individuals currently using Aduhelm can continue their treatment until November 1 and are advised to consult with their healthcare providers for potential alternatives.
Source: politico.com