FDA Approves Eli Lilly's Alzheimer’s Drug: Donanemab Offers New Hope for Early-Stage Patients

The Food and Drug Administration (FDA) on Tuesday approved Eli Lilly’s Alzheimer’s drug, donanemab, paving the way for a new treatment option that moderately slows the progression of the disease. This decision follows a thorough review by an FDA advisory panel, which unanimously recommended approval after assessing the drug's safety and efficacy.

Eli Lilly originally submitted donanemab for traditional approval last year, expecting the decision by early 2024. The FDA's requirement for an advisory panel meeting in June, following a delay in March, surprised the company but did not hinder the eventual approval. Now marketed as Kisunla, donanemab is a monoclonal antibody designed to target amyloid plaques in the brain. It is administered monthly via intravenous infusion to patients with early-stage Alzheimer's disease.

Clinical trials involving 1,700 patients over 18 months showed that donanemab slowed disease progression by 35% compared to a placebo. This equates to a delay in disease progression of approximately four months. Despite these promising results, the trial also revealed serious risks, including brain bleeding and swelling, which led to the deaths of three participants.

While anti-amyloid drugs like donanemab can significantly reduce amyloid beta plaques in the brain, questions remain about the clinical benefits and their overall impact on patients. More than six million Americans are currently diagnosed with Alzheimer’s, a number expected to rise as the population ages. Among them, about one million with early-stage disease could potentially benefit from this new treatment.

Joanne Pike, president and CEO of the Alzheimer’s Association, hailed the FDA's decision as significant progress. "Today's approval provides more options and greater opportunity for individuals to have more time. Having multiple treatment options is a significant advancement for all of us impacted by this devastating disease," Pike stated.

Donanemab is the third amyloid-targeting drug to receive FDA approval since 2021, following Biogen and Eisai's Aduhelm and Leqembi. Unlike Leqembi, patients can stop taking donanemab once amyloid plaques are sufficiently reduced, potentially lowering treatment costs and reducing the frequency of infusions.

Kisunla is priced at $695.65 per vial, translating to $32,000 annually, higher than Leqembi's estimated annual cost of $26,500. However, patients on Leqembi do not cease treatment. The actual cost for donanemab will vary depending on the duration of treatment. Medicare Part B is expected to cover the drug, with patients responsible for a 20% coinsurance after meeting their deductible.

Why This Matters: The approval of donanemab offers new hope for the millions affected by Alzheimer’s, providing an additional treatment option that may help slow disease progression in its early stages. This development marks a significant step forward in the ongoing battle against Alzheimer's disease.

Key Takeaways:

• The FDA has approved Eli Lilly's Alzheimer's drug, donanemab.
• Donanemab, now known as Kisunla, targets amyloid plaques in the brain.
• Clinical trials showed a 35% reduction in disease progression over 18 months.
• Serious risks, including brain bleeding and swelling, were noted in the trials.
• Kisunla's annual cost is $32,000, with Medicare covering a portion of the expense.