Biogen Prepares More Doubtful Phase III Results For FDA Scrutiny, This Time In ALS
Will Hope To Ride On Coattails Of Amylyx’s Thumbs Up
After the Aduhelm controversy, Biogen has another neurodegenerative disease drug which so far can only show efficacy against surrogate biomarkers – will the FDA be swayed again this time?
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Plans for launching a second Alzheimer's drug, lecanemab, will be scaled back compared to Aduhelm, the firm predicted, though partner Eisai has not finalized Biogen's commercial role yet.
The FDA gave full approval based on a Phase II study, without the need for Phase III confirmatory data, for Amylyx’s ALS drug Relyvrio but the $158,000 WAC could spark a debate over pricing.
After the Aduhelm controversy, Eisai/Biogen, Roche and Lilly are lining up Phase III results for their candidates which, against the odds, they hope could finally represent real progress in Alzheimer’s treatment. Scrip takes a look at the key questions surrounding the field as the drugs await their fate.