Indianapolis, Indiana – The Food and Drug Administration gave the green light on Tuesday to a new Alzheimer’s treatment called donanemab, marking the third addition to a novel class of drugs designed to slow the brain’s decline in patients grappling with the early stages of the disease.
Named Kisunla by Eli Lilly, the drug’s approval comes after facing numerous setbacks and delays in bringing the experimental treatment to the market, despite promising results from clinical trials. Eli Lilly announced that the drug will be available within weeks following the FDA’s approval.
Anne White, president of Eli Lilly’s neuroscience division, expressed excitement about the positive outcomes achieved by Kisunla for individuals with early symptomatic Alzheimer’s disease, stressing the importance of early treatment. She also highlighted ongoing efforts to enhance detection and diagnosis methods.
Last year, the FDA rejected Eli Lilly’s request for accelerated approval due to concerns about long-term safety data. However, after submitting additional data, the company anticipated a decision by the end of March. The decision was postponed as an advisory committee was convened by the FDA to address safety issues and efficacy measurements, ultimately voting overwhelmingly in favor of the drug’s benefits outweighing its risks for early-stage Alzheimer’s patients.
Donanemab, classified as an anti-amyloid monoclonal antibody, targets amyloid plaques in the brain, combating the protein buildup associated with Alzheimer’s disease. Patients in Eli Lilly’s trials received intravenous infusions of donanemab every four weeks, with the possibility of discontinuing treatment based on amyloid levels observed in brain scans.
According to data provided by Eli Lilly, nearly half of the patients in the trials saw a significant reduction in amyloid levels after a year of treatment, with no rebound effect observed post-treatment. Comparable drugs in the market include lecanemab, marketed as Leqembi by Eisai and Biogen.
Eli Lilly also emphasized other advantages of Kisunla over lecanemab, such as shorter and less frequent infusions, potentially leading to reduced treatment costs and fewer required infusions for patients.
The treatment will debut with a list price totaling $32,000 for a 12-month regimen, contingent on the duration of drug intake by patients. Medicare Part B participants will have similar coverage to lecanemab, paying a 20% coinsurance after the deductible is met. Eli Lilly pointed out that Kisunla’s treatment approach, allowing for limited-duration therapy and monthly infusions, could result in lower out-of-pocket costs and fewer infusions for patients compared to other amyloid-targeting therapies.
Evaluating donanemab’s effectiveness, Eli Lilly measured cognitive and functional decline with promising results, showing up to a 22% decline slowdown post-76 weeks of treatment initiation compared to placebo recipients. The company emphasized the treatment’s potential to delay progression to the next stage of Alzheimer’s disease effectively.
Concerns about side effects include amyloid-related imaging abnormalities seen in imaging scans, although typically asymptomatic, they have been associated with serious issues such as brain function impairments and seizures in some patients. Additionally, approximately 25% of donanemab trial participants displayed these abnormalities, with a few instances of severe brain hemorrhages leading to fatalities reported among recipients of the drug.
Furthermore, hypersensitivity reactions during infusions were experienced by around 3% of donanemab-treated patients, including severe allergic reactions in 0.3% of cases.
In conclusion, the approval of Kisunla by the FDA represents a significant breakthrough in the realm of Alzheimer’s treatment, offering new hope for patients in the early stages of the disease. With ongoing advancements in medical research and innovative therapies, the landscape of Alzheimer’s care continues to evolve towards more effective and patient-centered approaches.