Why did the FDA approve Aducanumab?

Based on the FDA’s assessment that the clinical trial data provided a strong suggestion of clinical benefit in the presence of a surrogate end point shown to be improved by the drug, and with solid data supporting the conclusion that the surrogate end point is reasonably likely to predict clinical benefit, we concluded …

What is Aducanumab used for?

Aducanumab Approved for Treatment of Alzheimer’s Disease. Aducanumab (Aduhelm™) has received accelerated approval as a treatment for Alzheimer’s disease from the U.S. Food and Drug Administration (FDA). This is the first FDA-approved therapy to address the underlying biology of Alzheimer’s disease.

When did aducanumab get FDA approval?

The US Food and Drug Administration (FDA) June 7 approval of the monoclonal antibody, aducanumab for Alzheimer’s disease—after decades of failed clinical trials that target the clearance of amyloid-beta—has elicited a decidedly mixed response from neurologists who treat dementia.

When will the FDA approve aducanumab?

On 7 June 2021, the FDA granted accelerated approval for aducanumab, a human recombinant anti-Aβ IgG1 monoclonal antibody and the first disease-modifying drug to be marketed for the treatment of AD5.

What type of drug is aducanumab?

Aducanumab is a monoclonal antibody (a protein that helps your immune system target other proteins), and it is designed to help your body remove something called amyloid beta from the brain. Amyloid beta is an important protein involved in the progression of Alzheimer’s disease.

Is aducanumab a monoclonal antibody?

Aducanumab (or BIIB037) is an IgG1 monoclonal antibody (mAb) that recognizes aggregated forms of Aβ, including epitopes in soluble and insoluble oligomers (Fig.

How was aducanumab approved?

In the case of aducanumab, the agency approved the drug based on dose-dependent results showing it reduced amyloid-beta plaques in the brains of people with AD, as seen in PET imaging.