Eli Lilly’s Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi

Eli Lilly’s Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi

Eli Lilly’s donanemab was rejected by the FDA last year due to a lack of long-term administration of the drug in an adequate number of patients.

Eli Lilly’s anti-amyloid therapy Kisunla (donanemab-azbt) finally meets success as it received full approval from the US Food and Drug Administration (FDA) for the treatment of individuals with mild cognitive impairment (MCI) or mild dementia stage of Alzheimer’s disease (AD).

The once-monthly injection for intravenous (IV) infusion is specifically approved for adults with early symptomatic AD, which includes people with MCI as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.

The approval comes after the FDA rejected the drug’s application for accelerated approval last year, asking for a minimum of 100 patients to receive the drug for at least 12 months. This year, Lilly was able to deliver on the request and despite the FDA delaying its decision to convene an advisory committee meeting, donanemab was able to secure a convincing approval.

The FDA advisory committee voted unanimously 11-0 in favor of Lilly’s drug on two voting questions about efficacy and safety.

In a news release announcing the approval, Lilly said Kisunla is the “first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.” Lilly seemingly highlighted this as an advantage over Biogen and Eisai’s rival Leqembi (lecanemab).

Another advantage of Kisunla is that it is administered as an IV infusion once a month, while Leqembi is given once every two weeks.

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Kisunla’s approved indication is almost the same as Leqembi’s. Both medications require confirmation of amyloid beta pathology in brain tissue prior to initiating treatment. They also both harbor a boxed warning for the risk of amyloid-related imaging abnormalities (ARIA), which are known side effects of antibodies that target beta-amyloid aggregates.

However, compared to Leqembi, Kisunla appears to have a less favorable safety profile on ARIAs, which is apparent on its label. Leqembi’s label requires four brain MRI scans before infusions, but Kisunla’s needs five. The extra required MRI scan isn’t surprising after Lilly showed that an MRI before the second infusion led to a 25 percent decrease in serious ARIA cases.

“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, executive vice president and president of Lilly Neuroscience, Eli Lilly and Company.

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Kisunla’s approval was based on results from the TRAILBLAZER-ALZ 2 Phase III study in which patients who achieved a visually negative PET scan of amyloid plaques were able to complete their Kisunla treatment and switch over to placebo for the rest of the study.

Kisunla led to an average reduction in amyloid plaques by 61 percent at six months, 80 percent at 12 months and 84 percent at 18 months compared to the beginning of the study.

At six months, 17 percent of people in the Kisunla group completed treatment, which increased to 47 percent after one year and 69 percent at 18 months.

Clinically, patients treated with Kisunla experienced a slower clinical decline of 22 percent compared to placebo. Among those who were less advanced in their disease, Kisunla led to a slowing of clinical decline of 35 percent compared with placebo. Additionally, individuals treated with Kisunla had up to a 39 percent lower risk of progressing to the next stage of the disease than those who got placebo.

Lilly has set Kisunla’s list price at $695.65 per vial with the total cost of treatment depending on when a patient completes treatment. Kisunla costs $32,000 for one year, which is higher than Leqembi’s annual price of $26,500 when it was launched in the US last year.

Coverage of the anti-amyloid class of drugs has already been worked out at the Centers for Medicare & Medicaid Services (CMS), which will make determining coverage easier for Lilly’s Kisunla. The agency announced in 2022 that it will cover monoclonal antibodies directed against amyloid for Alzheimer’s disease provided they have full FDA approval. Companies must also enroll patients in patient registries for the collection of real-world data to support the continued validation of their drugs.

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