Posted by Michael Wonder on 10 Feb 2021
Due to aducanumab’s new PDUFA date, ICER extends timeline for Alzheimer’s disease assessment
10 February 2021 - The ICER announced today it has extended its timeline for assessing the comparative clinical effectiveness and value of aducanumab (Biogen) for the treatment of Alzheimer’s disease.
On 29 January 2021, Biogen announced that the US FDA had extended the agency’s review period for aducanumab, delaying the investigational treatment’s Prescription Drug User Fee Act action date to 7 June 2021.
