The Food and Drug Administration approved Eli Lilly’s Alzheimer’s drug donanemab on Tuesday afternoon.

The drug will be marketed under the brand name Kisunla for treating adults with early symptomatic Alzheimer’s disease.

The regulatory greenlight comes less than a month after an FDA advisory committee unanimously backed the drug for approval.

“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” said Anne White, EVP and president of Lilly Neuroscience, in a statement. “Our deepest thanks to the patients and their loved ones for participating in our clinical programs and to Lilly scientists and collaborators persevering over decades of research. Each year, more and more people are at risk for this disease, and we are determined to make life better for them.”

The FDA previously rejected Lilly’s accelerated approval submission for donanemab in January 2023, requesting additional data from the pharma giant.

The approval now sets up a showdown between Kisunla and Leqembi, the Alzheimer’s treatment from Biogen and Eisai that was approved by the FDA almost one year ago.

While a forecast published in March 2023 projected that Leqembi would achieve sales totaling around $7.7 billion by 2028, it noted that the treatment would face stiff competition from donanemab upon FDA approval.

Still, Lee Brown, global sector lead for healthcare at research firm Third Bridge, wrote in a commentary published Tuesday afternoon that Leqembi may have a superior safety profile relative to Kisunla given a slightly different mechanism of action, which may allow for consistently lower ARIA risk with the latter treatment.

Brown added that Third Bridge specialists identified a need for additional guidance to establish a dosing protocol for Kisunla, especially as it relates to patient stratification, as well as the curtailment of treatment upon amyloid clearance.

Meanwhile, payers will likely have to start making coverage decisions on Kisunla fairly quickly as the drug is priced at $695.65 per vial and a 12-month treatment consisting of 13 infusions would run $32,000.

Jayne Hornung, chief clinical officer at market access intelligence firm MMIT, wrote in a commentary to MM+M that since payers cover Leqembi, it stands to reason that they would offer similar, if not broader, coverage for Kisunla.

“Kisunla provides hope to so many patients and caregivers affected by Alzheimer’s,” she wrote. “While it’s not a cure and there are a few safety concerns with this and similar products that target beta-amyloid plaque (donanemab caused brain swelling in about a quarter of patients and brain bleeding in as many as a third of patients, though most cases were mild), it is another treatment option which is meaningful to people dealing with this devastating disease.”

Following the announcement of the drug’s approval, Alzheimer’s patient advocacy groups weighed in to celebrate the news.

“This is real progress. Today’s approval allows people more options and greater opportunity to have more time,” said Alzheimer’s Association CEO Joanne Pike, DrPH said in a statement. “Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.”

Howard Fillit, M.D., cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, added that diagnosing and treating Alzheimer’s sooner has the potential to meaningfully slow disease progression, giving patients “invaluable time” to maintain their independence for longer.

“This approval is emblematic of the new era of Alzheimer’s research where we now have the first class of disease-modifying drugs that will eventually be used in combination with novel therapies — based on the biology of aging — that target all the underlying complexities of this disease,” he stated.

This story has been updated.

For a July 2024 article about Eli Lilly buying Morphic Holding for $3.2B, click here.