FDA Issues Complete Response for Lilly Alzheimer’s Drug
Lilly expects topline results from the confirmatory phase 3 trial in the second quarter of 2023 and plans to submit for full approval.
The FDA has issued a complete response letter for Eli Lilly’s accelerated approval submission of donanemab to treat patients with early Alzheimer’s disease. The agency indicated that there too few patients with at least 12 months of data provided in the submission.
In the complete response letter, the FDA specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of treatment with donanemab. The phase 2 trial had been designed to allow patients to complete their course of treatment when they reached a predefined level of amyloid plaque clearance. While the trial included more than 100 patients treated with donanemab, many patients were able to stop as early as six months. The FDA indicated that the data to meet the exposure expectation would likely need to include the unblinded controlled safety data from TRAILBLAZER-ALZ 2.
Lilly’s confirmatory phase 3 TRAILBLAZER-ALZ 2 trial is ongoing, with topline data expected in the second quarter of 2023. The company said this will form the basis of donanemab’s application for traditional approval.
Anne White
“We look forward to our upcoming confirmatory TRAILBLAZER-ALZ 2 phase 3 results and subsequent FDA submission… We anticipate this study will confirm the benefit and safety profile we observed in the TRAILBLAZER-ALZ phase 2 study and believe that patients and physicians will be well served by having the full phase 3 data available alongside our phase 2 data when they need to make treatment decisions,” Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly, said in a press release.
In November 2022, Lilly released early results from TRAILBLAZER-ALZ 4 — a head-to-head study against Eisai/Biogen’s Aduhelm (aducanumab-avwa) — showed that donanemab met all primary and secondary endpoints for the six-month primary outcome analysis. Brain amyloid plaque clearance was achieved in 37.9% of donanemab-treated patients compared with 1.6% of Aduhelm-treated patients at six months; in the intermediate tau subpopulation, 38.5% of patients treated with donanemab reached brain amyloid clearance compared with 3.8% of Aduhelm-treated patients.
FDA and EMA Accepts Applications for New Nusinersen Regimen
January 23rd 2025An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
Trump Impact on Medicare Drug Price Negotiations Uncertain
Published: January 22nd 2025 | Updated: January 22nd 2025Trump has reversed some of President Biden’s initiatives, including $2 monthly out-of-pocket cap on some generics and experimental pricing models for gene therapies. But so far the healthcare elements of the Inflation Reduction Act remain unchanged.
Read More
FDA Approves Spravato Nasal Spray as a Standalone Treatment for Major Depressive Disorder
January 21st 2025One-third of folks with major depressive disorder experience treatment-resistant depression (TRD), a condition that makes it more difficult to be treated by traditional oral antidepressants.
Read More
