Biogen Alzheimer's monoclonal antibody aducanumab was criticized by the FDA committee

CompileKe Ke

A few days ago, the US FDA took another blow to Biogen's Alzheimer's disease treatment drug aducanumab.

Recently, three members of the US FDA's Peripheral and Central Nervous System Drug Advisory Committee-Caleb Alexander, Scott Emerson and Aaron Kesselheim published their opposition to the drug in an article in JAMA.

They believe that the background of this drug has a long history, but it is puzzling.

But in October 2019, the two pharmaceutical companies announced plans to seek regulatory approval for the drug candidate aducanumab.

Although there are objections to some very complex data, the two companies believe that they have sufficient reasons to submit it to the US FDA and expect to submit it in the spring of 2020.

In November 2020, the Peripheral and Central Nervous System Drug Advisory Committee of the U.

In an article on JAMA, they reviewed the data for and against drugs, while also questioning the ability of doctors to effectively monitor the side effects of drugs.

"However, considering that these efficacy trials were stopped due to ineffectiveness, there is no reason to agree that only one of the two treatment groups in the two trials has a positive result, and both treatment groups have negative results, and there is currently a lack of convincing evidence.

The JAMA article pointed out that Bojian chose the data "unintentionally" precisely because these data are consistent with the results people hoped for.

In addition, three scientists working at the Bloomberg School of Public Health at Johns Hopkins University, the University of Washington, and Harvard Medical School criticized that “the US FDA and Biogen collaborated on the available data before the application was submitted.

Reference source: FDA Panel Takes Another Swing at Biogen's Alzheimer's Candidate