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The FDA calls for federal investigation of approval

Biogen shares fell on Friday after the head of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.

Acting FDA Commissioner Dr. Janet Woodcock asked the agency’s inspector general to investigate interactions between the US agency and Biogen representatives before approving the drug on June 7.

“I believe it is essential that the disputed events be reviewed by an independent body such as the Inspector̵

7;s Office to determine if any interaction between Biogen and FDA review staff was incompatible with FDA policies and procedures,” Woodcock wrote in a letter sent Friday.

Shares in Biogen fell past more than 3% after notification.

Biogenic stocks rose last month after the FDA approved the drug for biotechnology, the first drug cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new drug against the disease in nearly two decades.

The decision marked a departure from the advice of the Agency’s independent panel of external experts, who unexpectedly refused to approve the substance last autumn, citing non-convincing data. At least three members of the panel have withdrawn in protest after the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking for trace of the drug, scientifically known as aducanumab. STAT News and other media reported that FDA officials used a legislative shortcut to get approval to get the drug on the market faster.

The biogenic drug is targeted at a “sticky” compound in the brain known as beta-amyloid, which researchers expect to play a role in the devastating disease.

It is rare for an FDA chief to require an investigation into the agency’s own decisions. It is the latest setback for the company and the drug, which has been controversial since the promise shown in 2016.

In March 2019, Biogen withdrew the development of the drug after an analysis by an independent group revealed that it would be unlikely to work. The company then shocked investors several months later by announcing that it would still seek regulatory approval of the drug.

When Biogen sought approval for the drug in late 2019, the researchers said a new analysis of a larger data set showed that aducanumab “reduced clinical decline in patients with early-onset Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some speculating whether the clinical trial data were sufficient to prove the drug worked and whether approval could make it more difficult for other companies to enroll patients in their own drug trials.

Some doctors have said they will not prescribe aducanumab because of the mixed data package that supports the company’s application.

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