Biotech
Monday, March 11th, 2024 3:37 pm EDT
Key Points
- FDA delays approval decision for Eli Lilly’s Alzheimer’s treatment Donanemab, calling for a last-minute advisory meeting to review safety and efficacy in late-stage trial.
- The delay is unexpected and extends beyond the initially anticipated approval timeline, highlighting the significant challenges in developing Alzheimer’s treatments.
- Donanemab, like similar drugs, shows promise in slowing Alzheimer’s progression but raises concerns about safety issues such as brain swelling and bleeding, underscoring the urgency for effective care options in a disease affecting over 6 million Americans.
In a surprising move, Eli Lilly announced that the Food and Drug Administration (FDA) has postponed its decision deadline for the approval of their experimental Alzheimer’s treatment, donanemab. The FDA intends to convene a last-minute meeting with external advisors to further evaluate the drug’s safety and efficacy in a late-stage trial. This unexpected delay suggests that the potential approval of donanemab will likely be postponed beyond the first quarter of this year, with the initial deadline already pushed back from last year. Donanemab has shown promising results in slowing the progression of Alzheimer’s in late-stage trials, but like similar drugs, it raises concerns regarding safety issues such as brain swelling and bleeding. The FDA’s decision to seek additional input reflects the significant challenges and high stakes involved in developing effective treatments for Alzheimer’s, a disease that currently lacks a cure and affects millions of Americans. This delay poses another setback for Eli Lilly as it competes with Biogen and Eisai, whose Alzheimer’s treatment Leqembi received approval last year as the first medication proven to slow the disease’s progression in its early stages. Both Leqembi and Eli Lilly’s donanemab are monoclonal antibodies targeting the accumulation of amyloid plaque in the brain, a characteristic feature of Alzheimer’s. Despite labeling the delay as “unexpected,” Eli Lilly remains confident in donanemab’s potential to offer significant benefits to individuals with early symptomatic Alzheimer’s. The company plans to collaborate with the FDA and stakeholders to address concerns and provide further information. The FDA’s scrutiny will focus on a phase 3 trial spanning 18 months, involving over 1,700 patients in the early stages of Alzheimer’s with confirmed amyloid plaque presence. Key areas of interest include safety outcomes and the impact of the trial’s unique design on efficacy. Notably, Eli Lilly’s study allowed patients to discontinue treatment upon amyloid plaque clearance, unlike other Alzheimer’s drugs, including Leqembi. Despite positive efficacy results showing a 35% slower decline in cognitive function among patients receiving donanemab, concerns persist over its side effects, including brain swelling and bleeding observed in a significant percentage of participants, a pattern also seen with Leqembi.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/03/08/eli-lilly-alzheimers-drug-fda-approval-delayed.html
