Eli Lilly's Alzheimer's drug wins FDA approval

By Eleanor Laise

List price will be $32,000 for one year of infusions

An Eli Lilly & Co. Alzheimer's drug won Food and Drug Administration approval Tuesday, capping the medication's bumpy ride through the U.S. regulatory process and adding a second new treatment option for patients in earlier stages of the disease.

The Lilly drug, donanemab, will be marketed as Kisunla and was approved for patients with mild cognitive impairment as well as those in the mild-dementia stage of Alzheimer's disease.

Kisunla is set to compete with Biogen Inc. (BIIB) and Eisai Co.'s (ESALF) Leqembi, which was approved last year. Leqembi, however, is intended for ongoing treatment, whereas patients taking Kisunla may stop the therapy if their levels of amyloid, a hallmark of Alzheimer's disease, fall below a certain threshold.

That feature could potentially lower total treatment costs, although the sticker price for a year of Kisunla treatment will be higher than for a year of Leqembi. Twelve months of Kisunla treatment will involve 13 infusions and cost $32,000, Lilly said in a release Tuesday. Leqembi's list price is about $26,000 per year.

"As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients," Howard Fillit, co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation, said in a statement.

Kisunla may also have an advantage over Leqembi, some analysts say, because it involves once-monthly infusions that patients may consider less burdensome than biweekly Leqembi infusions. Biogen and Eisai, however, are also working on a once-monthly maintenance dose of Leqembi.

Nearly 7 million people in the U.S. are living with Alzheimer's, according to the Alzheimer's Association.

The approval comes after the FDA surprised Lilly earlier this year with the news that it would convene an advisory-panel meeting to review the late-stage trial of donanemab. The agency's decision pushed the drug's approval beyond the expected time frame of the first quarter.

At their meeting last month, the FDA's advisers unanimously agreed that donanemab has proven an effective treatment for earlier stages of Alzheimer's and that its benefits for those patients outweigh its risks. In a late-stage study, Kisunla reduced amyloid plaques by an average 80% after 12 months of treatment.

Like Leqembi, however, Kisunla has been linked with potentially severe side effects known as amyloid-related imaging abnormalities, which can involve swelling and bleeding in the brain.

Lilly's stock (LLY), which was weighed down earlier in the day by criticism from President Joe Biden and Sen. Bernie Sanders, a Vermont independent, regarding the price of obesity and diabetes drugs, was down 1.1% Tuesday afternoon. Biogen's stock was down 1.3% Tuesday afternoon and has dropped 11.6% in the year to date.

-Eleanor Laise

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07-02-24 1459ET

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