Food and Drug Commissioner Dr. Robert Califf praised results Eli Lilly announced Wednesday that a clinical trial showed its Alzheimer’s treatment donanemab slowed progression of the disease.
“This is just magnificent for a disease that’s affected so many people,” Califf said unprompted at the end of an interview hosted by the U.S.-India Chamber of Commerce on Wednesday.
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“And it’s not just these results. They are very consistent with the results that we had already seen, so we are cheering on here at the FDA,” he said at the chamber’s annual biopharma and health-care conference.
“We have to look at the data when it comes in before making a judgment, but if the data look as good as the press release — this is really, really exciting,” the commissioner said.
Patients who received Lilly’s monthly antibody infusion donanemab during an 18-month study demonstrated a 35% slower decline in memory, in thinking and in their ability to conduct daily activities compared with those who did not receive the treatment, according to the company’s data.
Lilly said donanemab also significantly reduced brain plaque associated with the disease.
The antibody treatment also carries risks of brain swelling and bleeding that can be severe and even fatal in rare circumstances. Three trial participants died from these side effects.
The company plans to submit its application for FDA approval of donanemab this quarter.
Califf said he does not make decisions about individual product approvals because he’s a political appointee. Full-time civil servants who are prohibited from having financial conflicts of interest make those decisions, the commissioner said.
Dr. Daniel Skovronsky, Lilly’s chief scientific and medical officer, told CNBC that the company is working to get donanemab approved and on the market as quickly as possible. Skovronsky said he believes the FDA feels the same sense of urgency.
“Every day that goes by, there are some patients who pass through this early stage of Alzheimer’s disease and become more advanced and they won’t benefit from treatment,” he said.
The FDA rejected Lilly’s request for expedited approval of donanemab in January. The agency asked the company for more data on patients who received the treatment for at least 12 months. Lilly said it did not have the data at the time because many patients were able to stop the treatment early due to donanemab clearing their brain plaque quickly.
Lilly now plans to ask the FDA for full approval of donanemab. This would presumably come with broader coverage from Medicare, which is crucial for patient access because most people who suffer from the disease are senior citizens.
Medicare is currently restricting access to Eisai and Biogen’s treatment Leqembi based on a policy that will only cover Alzheimer’s antibody treatments that receive expedited FDA approval for patients participating in clinical trials.
Leqembi slowed cognitive decline in patients with early Alzheimer’s disease by 27%.
The federal Centers for Medicare and Medicaid Services, or CMS, has promised to cover Alzheimer’s antibody treatments for all patients when such drugs receive full approval. Biogen and Eisai said they hope they will receive the full FDA greenlight July 6.
But CMS still plans to require patients to participate in registries that collect data on the medications. The Alzheimer’s Association has said such registries will continue to restrict access to treatments and has called on Medicare to drop those requirements.
Members of Congress and state attorneys general are also pushing for Medicare to provide full and unrestricted coverage of FDA-approved Alzheimer’s antibody treatments.
Medicare instituted the policy in the wake of the FDA’s controversial approval of Biogen and Eisai’s antibody treatment Aduhelm in June 2021. The agency cleared Aduhelm on an expedited basis over the objections of an independent advisory committee that warned the evidence did not demonstrate a clear clinical benefit.
Three members of the FDA advisory committee resigned over the agency’s decision on Aduhelm.
An investigation by Congress found the FDA approval of Aduhelm was “rife with irregularities.”