Aducanumab approval sets precedent for accelerated approval for neurodegenerative diseases

FDA’s accelerated approval of Biogen’s aducanumab to treat Alzheimer’s creates a path for approvals based on surrogate endpoints of other neurodegenerative disease therapies. It isn’t clear, however, if FDA will require more scientific rigor for using surrogate endpoints to approve conditions other than Alzheimer’s disease.

In a press briefing Monday, Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, noted that accelerated approvals based on surrogate endpoints have been widely used in oncology and said the Aduhelm aducanumab approval sets a precedent for their use to support approvals of treatments for neurodegenerative disorders. ...