BIIB - Biogen in the spotlight as FDA action date for Alzheimer's therapy approaches

The scientists, public advocacy groups, and analysts offer contrasting views as FDA is set to decide on aducanumab, the experimental therapy co-developed by Biogen (BIIB) and Japanese pharmaceutical company Eisai (ESALF) against Alzheimer’s disease.The marketing application for aducanumab was backed by data from two late-stage trials named EMERGE and ENGAGE.Noting the inadequacy of EMERGE study to prove its efficacy, an expert panel from the FDA previously declined to endorse the therapy. The regulator is not bound by their decision even though it generally follows the advice.In late January, Biogen shares surged when the FDA extended the review period for aducanumab by three months setting June 07 as the new action date.However, weighed down by negative comments on aducanumab, Biogen shares have well underperformed the broader market over the past year even as analysts remain upbeat over a favorable decision.Dr. Michael Greicius a neurology professor who served on the federal panel evaluating aducanumab is

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Biogen in the spotlight as FDA action date for Alzheimer’s therapy approaches