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FDA requires federal investigation for approval – News

Biogen Shares fell on Friday after the director of the Food and Drug Administration sought an investigation into the recent approval of the company’s Alzheimer’s disease drug, Aduhelm.

Dr. Janet Woodcock, Deputy FDA Commissioner, asked an inspector general to investigate the interaction between US agencies and Biogen representatives prior to drug approval on June 7.

“The case in question should be reviewed by an independent body, such as the Inspector General’s Office, to determine if the interactions that have occurred between Biogen and the FDA’s review staff are inconsistent with FDA policies and procedures. I think it’s important, “Woodcock wrote in a letter sent Friday.

Biogen strain fell More than 3% after announcement.

Biogen’s inventory surged last month after FDA approval Biotechnology company medicine, The first drug approved by US regulators to slow cognitive decline in people living with Alzheimer’s disease, and the first new drug for the disease in almost 20 years.

The decision showed a deviation from the advice of an independent panel of external expert agencies, Those who unexpectedly refused support Quoting unconvincing data, medicine last fall. At least three members of the panel resigned in protest with the approval of the agency.

Federal regulators have faced strong pressure from friends and family in Alzheimer’s disease to urgently pursue a drug scientifically known as aducanumab. STAT News and other media report to FDA officials Use regulatory shortcuts Get approval to get the drug to market faster.

Biogen’s drugs target a “sticky” compound in the brain known as beta-amyloid, which scientists expect to be involved in catastrophic disease.

FDA officials rarely request an investigation into the authorities’ own decisions. This is the latest setback for the controversial company and pharmaceuticals since it was seen as promising in 2016.

In March 2019, Biogen withdrew drug development after an analysis from an independent group revealed that it was unlikely to work. The company then announced that it would shock investors a few months later and eventually seek regulatory approval for the drug.

When Biogen sought approval for the drug in late 2019, scientists showed that aducanumab “reduced clinical decline in patients with early-stage Alzheimer’s disease,” with a new analysis of a larger dataset. Said that.

Alzheimer’s disease experts and Wall Street analysts are quickly skeptical that approval will allow other companies to enroll patients in their drug trials to see if clinical trial data is sufficient to prove the drug’s efficacy. I wondered if it would be difficult.

Some doctors They said they wouldn’t prescribe Aducanumab is for mixed data packages that support corporate applications.



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