US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s
Eisai/Biogen’s Leqembi Remains Lone Anti-Amyloid In US
Executive Summary
Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.
You may also be interested in...
Lilly’s Donanemab Slows Cognitive Decline; FDA Filing Imminent
The company’s anti-amyloid antibody succeeded in Phase III with efficacy at least on par with Eisai/Biogen’s Leqembi, but with ARIA-related deaths unseen with the rival therapy.
Lilly Strikes Out With The FDA For Second Time This Year With Mirikizumab CRL
With mirikizumab delayed until Lilly overcomes the FDA’s manufacturing concerns, the company has fallen behind on its goal of five approvals in 2023.
Lilly’s Solanezumab Reaches End Of Road As Donanemab Stays On Development Path
Solanezumab did not reduce the risk of progression in preclinical Alzheimer’s disease in the Phase III A4 study but it provided evidence that removing amyloid plaques – the mechanism of action for Lilly’s two remaining Phase III AD therapies, donanemab and remternetug – may be the key to efficacy.