Eli Lilly's Alzheimer's Drug Faces UK Agency Block After Biogen's Medicine Rejection Over Cost, Safety

The U.K.’s National Health Service (NHS) is expected to block the use of another Alzheimer’s treatment, Eli Lilly And Co‘s LLY donanemab, following the recent rejection of Biogen Inc‘s BIIB Leqembi (lecanemab) by the National Institute for Health and Care Excellence (NICE).

Although donanemab has shown greater effectiveness in slowing cognitive decline than lecanemab, experts believe it will face the same fate due to safety concerns and high costs.

Also Read: Eli Lilly’s Alzheimer’s Therapy’s Broad Label Reflects Regulatory Confidence in Anti-Amyloid Antibodies: Analyst.

Donanemab showed its ability to slow Alzheimer’s progression by 35%, compared to lecanemab’s 27%.

However, trials also revealed significant risks: one in three patients experienced brain bleeds, and one in four developed brain swelling, both conditions linked to amyloid-related imaging abnormalities.

These side effects occurred at double the rate seen with lecanemab, the Telegraph report added, raising doubts about donanemab’s approval by the Medicines and Healthcare Products Regulatory Agency (MHRA), even as both drugs have been approved in the U.S.

The cost of donanemab, projected to be higher than lecanemab, adds another hurdle.

NICE previously cited lecanemab’s annual cost—between £50,000 and £100,000 per patient—as a primary factor in its rejection.

Given that donanemab’s price is estimated to be around 25% higher, NICE’s decision to reject the drug seems increasingly likely. The body is unlikely to reverse its stance, especially after setting a precedent with lecanemab.

Last week, Biogen’s lecanemab became the first treatment for early AD (MCI and mild dementia due to AD) that targets an underlying cause of the disease to be authorized in a European country.

Despite the approval, the National Institute for Health and Care Excellence (NICE), in its guidance draft, said, “benefits of the new Alzheimer’s drug lecanemab are too small to justify the costs.”

Price Action: LLY stock is down 0.31% at $949.80 during the premarket session at last check Monday.

Read Next:

• Biogen/Eisai’s Popular Alzheimer’s Drug Leqembi Is Seeing Slow Adoption – Here’s Why.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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