Roche mulling quick filing for a tarnished Alzheimer’s drug as controversial Aduhelm OK electrifies the field — analyst
It’s increasingly unclear just how long Biogen will have the only major Alzheimer’s drug on the market.
According to a report from Jefferies, Roche has been in discussions with the FDA on whether they can file their own Alzheimer’s drug for accelerated approval in the coming months, following a pathway the FDA opened with their controversial decision to approve Biogen’s Aduhelm. That would be more than a year ahead of when Roche had originally hoped to file it and before the company got back data from their Phase III trials testing whether the drug can actually slow cognitive decline.
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