Aducanumab Approval Decision Delayed: Could This Be Good News?
Amendment Triggered Three-Month Review Extension
Even analysts who still doubt the FDA will approve the anti-amyloid antibody as the first disease-modifying Alzheimer’s treatment said aducanumab’s likelihood of approval has improved.
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Given mixed Phase III results for the Alzheimer’s drug and potentially severe side effects for the once-monthly infused therapy, ICER’s recommendation came in below analyst expectations.
The company has identified 600 sites of care to treat Alzheimer's patients with aducanumab in the US and is confident on its pricing strategy, management said.
Biogen has been granted new US patents for Tecfidera after generics already launched. It's unclear how Biogen will proceed but management could shed more light on the matter during the first quarter call.