The U.S. Food and Drug Administration seeks to investigate negotiations with Biogen before Alzheimer’s drug approval Reuters

Author: Manas Mishra

(Reuters)-The U.S. drug regulator called on Friday for an independent federal investigation of the interaction between its representatives and Biogen (NASDAQ:), which led to the company’s approval of Altz last month. Haimer’s disease drugs.

After the agency’s acting commissioner Janet Woodcock asked the Office of the Inspector General of the Department of Health and Human Services to investigate whether the negotiations were inconsistent with the regulatory agency’s policies, the drugmaker’s stock price fell 3%.

Biogen stated that it will cooperate with any investigations related to possible reviews.

Despite the strong opposition of the expert advisory group, the drug Aduhelm was approved by the U.S. Food and Drug Administration (FDA) on June 7, leading to the resignation of 3 of the 11 members.

Woodcock said in a letter posted on Twitter: “People are still worried… the contact between Biogen and FDA representatives during the review process. (https://

However, Woodcock said she was “very confident” in the integrity of the staff involved in the drug review.

Although one of Aduhelm’s two large-scale clinical trials failed to show benefit to patients, it was approved.

This move is based on evidence that it can reduce brain plaque, which may be the cause of Alzheimer’s disease, rather than proving that it can slow the progression of the fatal mental drain disease.

Stifel analyst Paul Matteis said that the latest developments are unlikely to affect Aduhelm’s status as an approved drug.

“Dr. Woodcock’s letter seems to be more of a strategy to relieve FDA pressure, and it revolves around the nature of the interaction/discussion rather than the actual nature of the approval decision,” he said.

A memo issued by the FDA last month showed that there was a clear struggle within the agency before its controversial decision to approve Aduhelm.

After months of internal deliberation, agency officials approved the drug using its accelerated approval route, which requires research to confirm that the drug is working as expected.