Lilly’s Donanemab Could Be A Near-Term Aduhelm Competitor
Company Will File For Accelerated Approval
Lilly said it will seek accelerated approval in the US based on Phase II data for its amyloid-clearing antibody, potentially narrowing Biogen/Eisai’s newly approved therapy Aduhelm’s time on the market as the only disease-modifying Alzheimer’s drug.
You may also be interested in...
Aduhelm commercialization was a bust, so Biogen’s next big hope for a potential blockbuster Alzheimer’s therapy is partner Eisai’s amyloid protofibril-targeting antibody lecanemab.
The Center for Medicare and Medicaid Services’ final decision on Medicare coverage favors anti-amyloid antibodies approved for Alzheimer’s disease based on efficacy rather than biomarker data.
The draft national coverage determination, released shortly before Lilly CEO David Ricks spoke at the J.P. Morgan Healthcare Conference, said Medicare will cover anti-amyloid antibodies only for patients in clinical trials, severely limiting commercial potential for Biogen’s Aduhelm and near-term competitors.