European Drug Regulator Gives Thumbs Down To Eli Lilly's Alzheimer's Drug, Analyst Says It Is Incremental Win For Biogen

European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an opinion that does not recommend Eli Lilly and Co's LLY donanemab be granted marketing authorization for the treatment of early symptomatic Alzheimer's disease. Lilly will seek re-examination by CHMP.

Kisunla (donanemab) is used to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.

Also Read: Alzheimer's Drugs From Eli Lilly And Biogen Still Deemed Too Costly For NHS Funding

In October 2024, Eli Lilly released results from the TRAILBLAZER-ALZ 6 Phase 3b study to investigate different dosing regimens of donanemab and their effect on amyloid-related imaging abnormalities with edema/effusion (ARIA-E) in adults with early symptomatic Alzheimer's disease.

The data showed a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer's disease.

On Thursday, Eli Lilly expanded its LillyDirect digital healthcare platform to offer connections to independent in-person and telehealth options for Alzheimer's patients in the U.S.

William Blair views "the CHMP's negative opinion on Kisunla as unsurprising, given the initial negative opinion for Leqembi, but nonetheless view it as an incremental win for Biogen Inc BIIB and Eisai."

Analyst Myles Minter writes that given that the CHMP changed its stance to support Biogen's Leqembi after a formal review, it's highly likely that Lilly will challenge Friday's decision. Historically, appeals in European marketing application authorization (MAA) filings have led to a reversal about 25% of the time.

William Blair estimates that Leqembi's sales in the EU could reach $1.3 billion by 2031. Analyst Minter sees Leqembi as a growth driver for Biogen, especially if advancements like a potential subcutaneous version get approved. However, sales are growing more slowly than expected.

The analyst reiterates Biogen's Outperform rating but acknowledges that without substantial M&A activity, this is a show-me story about returning to growth with the current portfolio.

Price Action: BIIB stock is down 1% at $138.92, and LLY stock is down 0.26% at $819.55 at the last check Friday.

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