Dive Brief:
- The Food and Drug Administration has finalized the date when an outside group of experts will convene to help the agency evaluate donanemab, a closely watched Alzheimer’s disease medicine that’s up for approval.
- The advisory committee meeting is scheduled for June 10. During it, experts in the fields of neuroscience and drug development will hear presentations from both FDA staff and donanemab’s developer, Eli Lilly. Committee members will then be able to ask questions and provide input on the evidence supporting Lilly’s marketing application.
- An approval verdict had been expected in the first quarter. But in early March, Lilly said the decision deadline would be pushed back because of the FDA’s plans to hold an advisory meeting. According to Lilly, the agency wants more information on donanemab’s safety and effectiveness, and to better understand results from a large clinical trial that found the medicine significantly slows the progression of Alzheimer’s.
Dive Insight:
After decades of work, Lilly may soon have a marketed product that changes the trajectory of Alzheimer’s.
That large trial enrolled more than 1,700 people who had early forms of the disease and tested positive for two proteins — amyloid beta and tau — that are linked to it. Participants were followed for 18 months, during which time they were given either a placebo or donanemab, which is specifically designed to clear amyloid beta from the brain.
Results showed that, across two key measuring systems used to assess cognition and the ability to perform daily tasks, those in the drug arm declined around 35% slower than those in the control group.
Lilly also designed the trial so that participants stopped receiving donanemab if brain scans found amyloid levels had gone under a certain threshold. According to the company, just over half of the drug arm completed treatment by one year, and nearly three-fourths were taken off by 18 months.
While those results convinced many on Wall Street that donanemab is poised to become a valuable product for patients as well as Lilly, regulators still appear to have questions. For example, when the FDA disclosed plans to hold an advisory meeting, Lilly said its “unique trial design” and the decision to only enroll participants who had some amount of tau were of interest to agency staff.
At the time, Anne White, president of Lilly Neuroscience, said “It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the [late-stage study] results and put donanemab's strong efficacy in the context of safety.”
Lilly now knows that opportunity will come on June 10, when the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee meets. The agency is currently establishing a docket for public comments. The docket will close on June 7, but any comments received on or before May 24 will be provided to the committee.