FDA Commissioner Dr. Robert Califf speaks at an event celebrating hearing aids being available over-the-counter at a Walgreens in Washington, D.C., Oct. 19, 2022.
Nathan Posner | Anadolu Agency | Getty Images
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.
“That is just magnificent for a disease that is affected so many individuals,” Califf said unprompted at the tip of an interview hosted by the U.S.-India Chamber of Commerce on Wednesday.
“And it is not just these results. They’re very consistent with the outcomes that we had already seen, so we’re cheering on here on the FDA,” he said on the chamber’s annual biopharma and health-care conference.
“We’ve to have a look at the info when it is available in before making a judgment, but when the info look nearly as good because the press release — this is basically, 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 pondering and of their ability to conduct every day activities compared with those that didn’t receive the treatment, in response to the corporate’s data.
Lilly said donanemab also significantly reduced brain plaque related to the disease.
The antibody treatment also carries risks of brain swelling and bleeding that may be severe and even fatal in rare circumstances. Three trial participants died from these unwanted side effects.
The corporate plans to submit its application for FDA approval of donanemab this quarter.
Califf said he doesn’t make decisions about individual product approvals because he’s a political appointee. Full-time civil servants who’re 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 corporate is working to get donanemab approved and available on the market as quickly as possible. Skovronsky said he believes the FDA feels the identical sense of urgency.
“On daily basis that goes by, there are some patients who go through this early stage of Alzheimer’s disease and grow to be more advanced and so they won’t profit from treatment,” he said.
The FDA rejected Lilly’s request for expedited approval of donanemab in January. The agency asked the corporate for more data on patients who received the treatment for not less than 12 months. Lilly said it didn’t have the info on the time because many patients were in a position to stop the treatment early as a result of donanemab clearing their brain plaque quickly.
Lilly now plans to ask the FDA for full approval of donanemab. This is able to presumably include broader coverage from Medicare, which is crucial for patient access because most individuals that suffer from the disease are senior residents.
Medicare is currently restricting access to Eisai and Biogen’s treatment Leqembi based on a policy that may 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 may receive the complete FDA greenlight July 6.
But CMS still plans to require patients to take part in registries that collect data on the medications. The Alzheimer’s Association has said such registries will proceed to limit 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 supply full and unrestricted coverage of FDA-approved Alzheimer’s antibody treatments.
Medicare instituted the policy within 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 didn’t reveal a transparent clinical profit.
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.”
