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Lilly’s donanemab may outclass aducanumab, but questions remain

By Brian Buntz | July 2, 2021

Eli LillyFDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares.

But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist.

Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021 under the accelerated approval pathway. As a result, Truist has pushed its launch assumption up two years to 2023 and raised its sales projections for the amyloid-plaque clearing drug.

Assuming the amyloid hypothesis is valid, donanemab holds promise as a potential disease-modifying therapy. In a Phase 2 trial, the investigational drug appeared to promote roughly twice the plaque clearance at 18 months as aducanumab did. Earlier studies also suggested that donanemab cleared plaque aggressively. The potential cognitive benefits of that clearance, however, remain unclear.

[Related: Lilly’s push for accelerated FDA approval of Alzheimer’s drug donanemab]

The analyst firm’s base case assumption for donanemab is that it would cost marginally less than aducanumab — $50,000 versus $56,000 annually.

Eisai’s and Biogen’s lecanemab has also recently received breakthrough therapy designation from the FDA to treat Alzheimer’s disease.

While FDA’s approval of aducanumab may have boosted donanemab’s prospects, the latter drug’s success is not guaranteed. Speaking in a call with UBS analysts, Dr. Jonathan Jarow, the CEO of the consultancy FDA Solutions (Miami), has projected that donanemab currently has a roughly 50/50 shot at approval.

Lilly is currently recruiting patients for a Phase 3 trial of the drug known as TRAILBLAZER-ALZ 2. The Phase 2 study is known as TRAILBLAZER-ALZ.


Filed Under: clinical trials, Drug Discovery, Neurological Disease
Tagged With: Aducanumab, Alzheimer's disease, Alzheimer’s, amyloid plaque, Biogen, donanemab, Eisai, Eli Lilly, FDA, Lilly, TRAILBLAZER-ALZ 2, Truist
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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