European Drug Regulator Provides Thumbs Down To Eli Lilly’s Alzheimer’s Drug, Analyst Says It Is Incremental Win For Biogen – Eli Lilly (NYSE:LLY)

European Medicines Company’s (EMA) Committee for Medicinal Merchandise for Human Use (CHMP) issued an opinion that doesn’t advocate Eli Lilly and Co’s LLY donanemab be granted advertising and marketing authorization for the remedy of early symptomatic Alzheimer’s illness. Lilly will search re-examination by CHMP.

Kisunla (donanemab) is used to deal with adults with early symptomatic Alzheimer’s illness (AD), which incorporates delicate cognitive impairment (MCI) or delicate dementia stage of illness.

Additionally Learn: Alzheimer’s Medication From Eli Lilly And Biogen Nonetheless Deemed Too Pricey For NHS Funding

In October 2024, Eli Lilly launched outcomes from the TRAILBLAZER-ALZ 6 Part 3b examine to research completely different dosing regimens of donanemab and their impact on amyloid-related imaging abnormalities with edema/effusion (ARIA-E) in adults with early symptomatic Alzheimer’s illness.

The information confirmed a discount in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) on the 24-week major endpoint for individuals receiving a barely modified titration of donanemab in adults with early symptomatic Alzheimer’s illness.

On Thursday, Eli Lilly expanded its LillyDirect digital healthcare platform to supply connections to impartial in-person and telehealth choices for Alzheimer’s sufferers within the U.S.

William Blair views “the CHMP’s damaging opinion on Kisunla as unsurprising, given the preliminary damaging opinion for Leqembi, however nonetheless view it as an incremental win for Biogen Inc BIIB and Eisai.”

Analyst Myles Minter writes that provided that the CHMP modified its stance to help Biogen’s Leqembi after a proper assessment, it is extremely seemingly that Lilly will problem Friday’s determination. Traditionally, appeals in European advertising and marketing utility authorization (MAA) filings have led to a reversal about 25% of the time.

William Blair estimates that Leqembi’s gross sales within the EU might attain $1.3 billion by 2031. Analyst Minter sees Leqembi as a development driver for Biogen, particularly if developments like a possible subcutaneous model get permitted. Nonetheless, gross sales are rising extra slowly than anticipated.

The analyst reiterates Biogen’s Outperform score however acknowledges that with out substantial M&A exercise, this can be a show-me story about returning to development with the present portfolio.

Worth Motion: BIIB inventory is down 1% at $138.92, and LLY inventory is down 0.26% at $819.55 on the final test Friday.

Learn Subsequent:

Picture by way of Shutterstock