1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Lilly’s Donanemab Slows Cognitive Decline; FDA Filing Imminent

Full Approval Sought After Accelerated Nod Denied Previously

 
• By Mandy Jackson

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.

Alzheimer's disease on MRI
Donanemab slowed cognitive decline in Phase III • Source: Shutterstock

Eli Lilly and Company remains months behind Eisai Co., Ltd./Biogen, Inc. in bringing an anti-amyloid antibody to market, but with Phase III TRAILBLAZER-ALZ 2 trial results on 3 May showing a 35% slowing in clinical decline for early Alzheimer’s patients treated with donanemab, Lilly plans to file for US Food and Drug Administration during the second quarter of 2023. The data appear to show greater efficacy than seen with Eisai/Biogen’s Leqembi (lecanemab) last year, although with greater risks.

Lilly said it intends to work with the FDA and other regulators “to achieve the fastest path to traditional approvals.”...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Otsuka’s IgAN Data Top Some Vera Results, But To What End?

 
• By Joseph Haas

Otsuka bested Vera on Phase III immunoglobulin A nephropathy data for proteinuria, but analysts wonder if the difference is especially meaningful.

ASCO: Kite’s Glioblastoma CAR-T Highlights Solid Tumor Progress

 
• By Alaric DeArment

The company presented Phase I data for CART-EGFR-IL13Rα2, showing patient responses in the notoriously hard-to-treat and deadly brain cancer.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

Will Pfizer Walk Away From Arvinas After PROTAC Disappointment?

 
• By Andrew McConaghie

Arvinas and Pfizer have just filed the potential first-in-class protein degrader vepdegestrant, but its diminished commercial prospects after mixed Phase III data mean Pfizer could exit.

More from R&D

Deal Build-Up Amid Early ‘Deep’ Response For IGI’s Trispecific In Myeloma

 
• By Anju Ghangurde

IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?

Ascletis Plans China Submission After Positive Denifanstat Phase III Acne Results

 
• By Sushmita Panda

Once-daily oral FASN inhibitor denifanstat meets all endpoints in a Chinese Phase III trial for moderate-to-severe acne, paving the way for a regulatory submission in China.

New Regenxbio DMD Data Support Gene Therapy Accelerated Approval

 
• By Joseph Haas

Regenxbio reported functional and biomarker data from an ongoing study of RGX-202, which it hopes to file for approval in Duchenne muscular dystrophy in 2026.