Biogen moved a significant step closer to winning approval for what would be the first new Alzheimer’s drug in the US for decades after staff at the country’s regulator said there was “substantial evidence” it was effective, adding $15bn to the company’s market value.
The Food and Drug Administration on Wednesday published a positive clinical review on the application for aducanumab, a potential treatment for the neurological disease that affects 5.7m people in the US alone.
The FDA reviewers addressed concerns that there was not enough evidence that the drug worked, after one of Biogen’s two clinical trials failed. They said the failed trial did not “meaningfully detract” from the results of the successful one, which it called “robust and exceptionally persuasive”.