In a potentially huge setback for Biogen (BIIB), a European regulatory panel signaled that it is unlikely to recommend the company’s controversial Alzheimer’s treatment should be approved. And while a final decision by the European Medicines Agency will not be known until next month, Wall Street is quickly discounting the possibility the medication will generate revenues from the vast European market.
The move comes amid intensifying pressure on Biogen.
Its Alzheimer’s medicine, which is called Aduhelm, was approved earlier this year by the U.S. Food and Drug Administration despite heated debate over effectiveness that sparked fresh concerns about regulatory standards. And the $56,000 annual price tag is causing anxiety about the financial strain that may be placed on the U.S. health care system – both public and private payers.
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