04:02 PM EDT, 07/02/2024 (MT Newswires) -- Eli Lilly ( LLY ) has received approval from the US Food and Drug Administration for its Kisunla, or donanemab, drug to treat adults with early symptomatic Alzheimer's disease.

The once-monthly injection is approved for people with mild cognitive impairment or mild dementia stage of Alzheimer's disease, the drugmaker and the FDA said in separate Tuesday statements.

In March, Lilly said donanemab would be delayed beyond the first quarter as the FDA sought more information about a late-stage trial.

Results from a phase 3 study showed that patients who were the least advanced in the disease saw the strongest results with Kisunla, the company said Tuesday. Trial participants were analyzed over 18 months in two groups, with the Kisunla treatment "significantly" slowing clinical decline in both, according to Lilly.

Patients treated with Kisunla who were less advanced in their disease showed a 35% slowing of decline, compared with placebo on the integrated Alzheimer's disease rating scale, which measures memory, thinking, and daily functioning. Among the two groups analyzed, patients treated with Kisunla had up to a 39% lower risk of advancing to the next clinical stage of disease than those taking placebo.

"Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease, who urgently need effective treatment options," said Anne White, president of Lilly Neuroscience.

Each vial of Kisunla is priced at $695.65, the company said, adding that the total cost will vary based on when patients complete treatment. According to the FDA's dosing instructions, prescribers can consider stopping the dosing based on removal of amyloid plaques to minimal levels as observed on amyloid positron emission tomography imaging.

"The potential to complete treatment after a limited-duration course of therapy, along with 30-minute infusions once per month, could result in lower patient out-of-pocket treatment costs and fewer infusions compared to other amyloid-targeting therapies," Lilly said.

The company is studying donanemab in various clinical trials, including one that's focused on preventing symptomatic Alzheimer's disease in participants with preclinical disease.

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