Biogen’s stock dropped on Friday after the FDA’s commissioner asked for an inquiry of the company’s recent approval of Aduhelm, an Alzheimer’s treatment. Prior to the drug’s approval on June 7, Acting FDA Commissioner Dr. Janet Woodcock urged the Office of Inspector General to look into interactions between the US agency and Biogen personnel. In a letter sent Friday, Woodcock wrote, “I believe it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions between Biogen and FDA review staff were inconsistent with FDA policies and procedures.” Following the announcement, Biogen’s stock dropped by more than 3%. Biogen’s shares soared last month after the FDA approved the biotech company’s treatment, the first pharmaceutical to be approved by US regulators to delay cognitive deterioration in adults with Alzheimer’s disease in nearly two decades. The agency’s independent panel of outside experts had unexpectedly failed to endorse the medicine last fall, citing weak data, and this decision marked a shift from their advice. Following the agency’s decision, at least three members of the panel have resigned in protest. Friends and family members of Alzheimer’s patients put pressure on federal regulators to fast-track the medicine, known scientifically as aducanumab. FDA officials reportedly utilized a regulatory shortcut to win approval in order to get the medicine on the market faster, according to STAT News and other media outlets. Biogen’s medicine targets beta-amyloid, a “sticky” substance in the brain that experts believe plays a role in the deadly disease. An FDA commissioner calling for an investigation of the agency’s own actions is unusual. It’s the latest setback for the company and the medicine, which has sparked debate since its initial success in 2016. Biogen halted development of the medicine in March 2019 after an independent investigation found that it was unlikely to succeed. After a few months, the business surprised investors by announcing that it would pursue regulatory approval for the medicine after all. A fresh examination of a larger dataset indicated aducanumab “reduced clinical decline in individuals with early Alzheimer’s disease,” according to Biogen scientists when the medicine was submitted for approval in late 2019. Alzheimer’s experts and Wall Street analysts were hesitant at first, with some questioning if the clinical trial data was sufficient to confirm the medicine’s effectiveness, and whether approval would make it more difficult for rival businesses to recruit patients in their own treatment trials. Because of the mixed data package supporting the company’s application, several doctors have stated that they will not prescribe aducanumab./n
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