Lilly’s Donanemab, Now At FDA, Poised To Join Alzheimer’s Armamentarium

Lilly expects US approval of the anti-amyloid therapy by the end of the year. Full Phase III data were detailed at AAIC.

Fighter Jets
Lilly believes donanemab is well positioned to join the Alzheimer's fight • Source: Shutterstock

Eli Lilly and Company’s donanemab could be approved by the US Food and Drug Administration by the end of the year, positioning it as the second anti-amyloid therapy for Alzheimer’s disease to secure a full approval by the agency after Eisai Co., Ltd./Biogen, Inc.’s Leqembi (lecanemab).

More from Clinical Trials

Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
• By 

Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.

Pipeline Watch: 13 Approvals And 13 Phase III Trial Updates

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Roche’s Brain Shuttle Delivers In Alzheimer’s, Moves Ahead To Phase III

 

By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.

Compass’ Bispecific BTC Contender Meets Phase II/III Endpoint

 
• By 

Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.

More from R&D

AZ’s Oncology R&D Head On China’s Scientific Promise And True Innovation

 

AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.

BeiGene Ends Anti-TIGIT Development In Lung Cancer

 
• By 

BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.

Edgewise’s HCM Candidate May Provide Advantages Over BMS’s Camzyos

 
• By 

With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.