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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

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Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor For IPF

 
• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

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.

More from R&D

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

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.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.