FDA Approval: Groundbreaking Alzheimer’s Treatment Hits Market, Promises to Slow Disease Progression

WASHINGTON, DC – The Food and Drug Administration has recently approved a new treatment for Alzheimer’s disease called donanemab, marking the third addition to a new class of drugs designed to slow down the brain’s decline in patients experiencing the early stages of the disease.

Developed by Eli Lilly and branded as Kisunla, donanemab’s approval comes after overcoming years of setbacks and delays in bringing the experimental Alzheimer’s treatment to market. Eli Lilly expects to make the drug available within weeks following the approval.

According to Anne White, president of Eli Lilly’s neuroscience division, Kisunla showed significant results for individuals with early symptomatic Alzheimer’s disease, emphasizing the importance of early detection and treatment. The FDA had previously rejected Eli Lilly’s request for accelerated approval due to concerns over long-term safety data, but after providing additional data, the agency ultimately approved the drug.

Donanemab is classified as an anti-amyloid monoclonal antibody, targeting amyloid plaques in the brain associated with Alzheimer’s disease. Eli Lilly’s trials showed that almost half of patients were able to effectively clear out amyloid after a year of treatment, with no rebound of amyloid plaque observed post-treatment.

In terms of cost, Eli Lilly plans to launch Kisunla with a list price totalling $32,000 for 12 months of treatment, with the actual cost varying depending on the duration of treatment. Medicare Part B will cover the drug similarly to lecanemab (Leqembi), with patients paying a 20% coinsurance after meeting their deductible.

Effectiveness of donanemab was primarily measured through cognitive and functional decline scales, showing a up to 22% reduction in decline compared to placebo recipients. The drug was found to delay progression to the next stage of Alzheimer’s disease, indicating its potential clinical benefits.

However, the drug does come with side effects, including amyloid-related imaging abnormalities, reactions to infusions, and hypersensitivity for some participants. These issues were seen in a quarter of patients in Eli Lilly’s trials, with some experiencing adverse events such as brain hemorrhages.

In conclusion, the approval of donanemab represents a significant step in addressing Alzheimer’s disease, offering a new treatment option for patients in the early stages of the condition. The drug’s potential benefits and risks highlight the complexities of treating Alzheimer’s disease and the ongoing efforts to improve patient outcomes.