Eisai Bets On Accelerated Approval For Biogen-Partnered Lecanemab
Filing Before Pivotal Data Beats Lilly’s Pre-Phase III Submission
Following Biogen’s lead with Aduhelm, the first disease-modifying Alzheimer’s therapy approved in the US, Eisai began a rolling BLA submission for lecanemab (BAN2401) ahead of next year’s Phase III results.
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Priya Singhal took over as Biogen's top R&D leader on an interim basis after Al Sandrock’s unexpected retirement. "I understand that this is a challenging time," she told Scrip.
Company execs say there has been four-fold increase in doctors infusing the Alzheimer’s drug and despite lack of support from major institutions, individual physicians at Cleveland Clinic and elsewhere have voiced support for Aduhelm. Biogen is “cautiously optimistic” about lecanemab Phase III trial.
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.