FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug

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FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

On June 07, 2021, FDA announced the approval of Biogen’s Aduhelm (aducanumab), a new monoclonal antibody for treating Alzheimer’s disease, using the accelerated approval pathway. Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease and is the first new treatment approved for the disease since 2003, the agency stated in its press release.

FDA also noted in its press release that this drug is the first therapy that targets the fundamental pathophysiology of the disease. Researchers evaluated Aduhelm’s efficacy in three separate double-blind, randomized, placebo-controlled dose-ranging studies that represent 3482 patients in total. The results from the studies showed that patients receiving the treatment had significant dose-and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque, the plaques being the hallmark of Alzheimer’s disease. These results support the accelerated approval of the drug.

Under the accelerated approval provisions, FDA is requiring Biogen to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, FDA may initiate proceedings to withdraw approval of the drug.

Aduhelm was also granted fast track designation, which serves to expedite the development and review of drugs that are intended to treat serious conditions when initial evidence shows that the drug has potential to address an unmet medical need.


“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” said Patrizia Cavazzoni, MD, director of FDA’s Center for Drug Evaluation and Research, in the press release. “Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”

Source: FDA