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USA: Controversial approval process for Alzheimer’s drug to be investigated

USA: Controversial approval process for Alzheimer’s drug to be investigated

The acting head of the US drug agency FDA wants to achieve an investigation into the approval of a controversial new Alzheimer’s drug in what is considered to be a very unusual step. You have applied to the US Department of Health for an independent review of the contacts between representatives of your agency and the manufacturer Biogen, wrote Janet Woodcock on Twitter.

“We believe that an independent assessment is the best way to determine if any interactions between the manufacturer and agency review personnel have been inconsistent with FDA guidelines and procedures.”

The FDA approved the drug with the active ingredient aducanumab in June. Aducanumab is the first novel treatment method against the neurodegenerative disease that has been approved since 2003, it was said at the time. The drug is designed to be given as a monthly infusion to patients with early-stage Alzheimer’s disease and is designed to stop the decline of mental power.

Contradictory information in studies

How well aducanumab works, however, is controversial: An internal advisory committee of the FDA had spoken out against the approval, several scientists had expressed their public skepticism. Stopped studies with the drug called Aduhelm, under which the active ingredient is marketed, probably did not provide any clear information as to whether the drug slows down cognitive decline or not. Therefore, the agency approved the drug instead in a special approval process that requires less data. For this purpose, representatives of the authority are said to have met regularly with managers from the manufacturer. Biogen boss Michel Vounatsos described the FDA approval as a “historic moment”.

Recently, there had been repeated reports of unusually close collaboration between Biogen and FDA staff. She believes an independent investigation will help maintain confidence in the FDA’s decision-making, Woodcock continued. If there is an investigation, the agency will cooperate fully. “The trust of the American public, especially in these troubled times, is of paramount importance to the FDA.”

The Democrats in the House of Representatives have also launched an investigation into the case. They also look critically at the price of the drug. Treatment with it is said to cost $ 56,000 a year, or around 47,000 euros. The Senate could also deal with the issue. The manufacturer has announced that it will cooperate in any investigation into the approval process.

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