American biotech firm Biogen Inc. scored regulatory approval for its Alzheimer’s disease therapy, Bloomberg reported.
- Biogen’s aducanumab is the first drug that secured the approval of the United States Food and Drug Administration to slow the progression of Alzheimer’s disease. It will be sold under the brand name Aduhelm.
- Aducanumab seeks to remove a protein called amyloid attributed to memory loss and clogs brains of Alzheimer’s patients. Therapies in the market help with the symptoms but do not reduce the damages.
- The FDA said the application met requirements for “accelerated approval” and said that benefits outweighed the risks of the therapy. This means further studies are needed and it could be removed if findings do not indicate benefits.
- Scientists have flagged mixed results of the clinical trials as the drug was found to be overall in a giant trial while another found that high doses slowed progression by 22% over 18 months.
Proponents argued that one trial succeeded, while skeptics said another trial is needed as a tiebreaker for the drug. BIIB is up 0.10%.