Biogen Gets FDA Nod For Controversial Alzheimer's Drug; First Treatment Approval For The Disease In 18 Years

Biogen Gets FDA Nod For Controversial Alzheimer's Drug; First Treatment Approval For The Disease In 18 Years

After months of wait, Biogen Inc. BIIB has finally achieved success by taking its controversial Alzheimer's treatment past the finish line.

FDA Okays Aducanumab: Biogen's biologics license application for aducanumab, its investigational Alzheimer's treatment, received FDA approval under the accelerated approval pathway.

Aducanumab, which will go with the tradename Aduhelm, has the distinction of being the first Alzheimer's treatment approved since 2003.

More importantly, it's the first treatment directed at the underlying pathophysiology of Alzheimer's disease, the presence of amyloid beta plaques in the brain, the FDA said in a statement. Aduhelm works by reducing plaques and will also lead to a reduction in the clinical decline of dementia.

The FDA conceded that data included in Biogen's submission were highly complex and left residual uncertainties regarding a clinical benefit.

"At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward," the agency said.

The FDA said it took into account clinical trial findings, Adcom's input, and perspectives of the patient community, and concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweighed the risks of the therapy.

The regulator also highlighted the acute need for a therapy for Alzheimer's, given more than 6 million Americans are living with Alzheimer's disease and the disease is the sixth leading cause of death in the U.S. This number is expected to grow as the population ages.

Biogen's Long-Winding Route to Approval: After giving up on aducanumab due to not-so-promising late-stage study results, Biogen revived it following a subset analysis of data that ultimately convinced the FDA to accept a regulatory filing for approval.

Aducanumab was subsequently put to Adcom test but could not win the backing of the FDA panel.

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