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Biogen Alzheimer’s drug approved

Biogen Alzheimer’s drug approved

FDA approves Biogen’s Alzheimer’s drug. Annual maintenance dose priced at $56,000.

Where: United States

The Facts

▪ On June 7th, the Food and Drug Administration granted accelerated approval to Aducanumab (commercially, Aduhelm) for Alzheimer’s disease treatment.

▪ Biogen and Eisai Co. Ltd. developed Aduhelm – according to Biogen, the drug “is an antibody that binds to and may reduce amyloid plaques from the brain, potentially slowing the progress of the disease.”

▪ According to the Biogen website, Aduhelm clinical trials showed 59-71% amyloid-beta plaque reduction in patients at “18 months of treatment” – following FDA approval Biogen and Eisai shares rose by 38.34% and 56.27%.

▪ The FDA’s Center for Drug Evaluation and Research director Dr. Patrizia Cavazzoni wrote, “There has been considerable public debate on whether Aduhelm should be approved… Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit.”

▪ Dr. Cavazzoni continued, “In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

▪ Under the accelerated approval pathway, the FDA requires the company to continue studying the drug’s efficacy in a post-approval trial to prove clinical gain.

▪ Dr. Cavazzoni said, “If the clinical benefit is not confirmed, or if the study is not conducted in a timely manner, we may withdraw this therapy’s approval.”

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