Biogen, in Reversal, Will Seek FDA Approval for Alzheimer’s Drug - News Summed Up

Biogen, in Reversal, Will Seek FDA Approval for Alzheimer’s Drug


Biogen Inc. BIIB 26.11% will seek regulatory approval early next year for an Alzheimer’s disease drug that had been considered a lost cause after the company pulled the plug on late-stage studies because of disappointing results. The new data indicated the drug did work in patients in one of the studies who received the highest dose. But it wasn’t until the company’s latest meeting with the FDA on Monday that Biogen gained confidence to submit the drug called aducanumab for approval, he said. When the company and partner Eisai & Co. said in March they would terminate the late-stage studies, Biogen lost about $18 billion in market value. After discontinuing the trials, Biogen reanalyzed the data based on additional data from patients who had completed the trial between December and March.


Source: Wall Street Journal October 22, 2019 11:44 UTC



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