Monday, 7 June 2021 18:19
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The US FDA on Monday accelerated approval for the Alzheimer’s drug aducanumab from Biogen.
The FDA decided on rapid approval after it concluded that the drug’s benefits outweigh its risks. An independent FDA advisory committee voted against the approval. It is very unusual for the FDA to ignore this advice.
Billy Dunn of the FDA says he has listened carefully to the comments of the advisory committee. “Ultimately, the decision to use aducanumab rests with patients, their families and healthcare professionals,” Dunn said. “But it’s clear that the FDA has conducted a rigorous investigation, taking into account that there is a huge demand for such an Alzheimer’s drug.”
It is the first time since 2003 that the FDA has introduced a treatment for Alzheimer’s. The Amsterdam-listed Vivoryon is currently also conducting clinical studies into a treatment against the disease.
Biogen shares rose slightly on Monday evening. Vivoryon closed more than 6 percent higher on the Damrak.
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