Biogen, Inc.’s push to bring Aduhelm (aducanumab-avwa) to market as the first disease-modifying Alzheimer’s therapy seems to have backfired one year later. Instead of changing the lives of millions of patients and boosting the company’s profile and profits, the success of gaining accelerated approval from the US Food and Drug Administration was followed by commercial failure.
Aduhelm’s endorsement by the FDA created doubt about clinical benefit because the accelerated approval was based on the amyloid-clearing antibody’s effect on a biomarker rather than its ability to slow cognitive decline, That
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