FDA Commissioner Praises Eli Lilly’s Alzheimer’s Treatment Results

Dr. Robert Calif of the Food and Drug Administration praised the results, and Eli Lilly announced Wednesday that its Alzheimer’s drug, donanemab, has shown in clinical trials to slow the progression of the disease.

“This is great for a disease that is affecting so many people,” Caliph said at the end of an interview hosted by the Indian Chamber of Commerce on Wednesday.

“And these are not the only results. These results are very consistent with what we’ve already seen, which is why we’re rooting for them here at the FDA.

“We’ll have to look at the data before making any judgments, but if the data looks like the press release, this is really, really exciting,” the commissioner said.

The company’s data show that patients who received Lilly’s monthly antibody infusion donanemab in an 18-month study experienced a decline in memory, thinking and ability to perform daily activities compared to patients who did not receive treatment35. % was shown to be slow.

Donanemab also significantly reduced brain plaques associated with the disease, Lilly said.

Antibody therapy also carries risks of brain swelling and bleeding, which in rare cases can be serious and even fatal.Three trial participants died from these side effects.

The company plans to submit an application for FDA approval of donanemab this quarter.

Caliph said he is politically appointed so he does not make decisions about approving individual products. said the commissioner.

Lilly’s chief scientific and medical officer, Dr. Danielle Skoblonski, told CNBC that the company is working to get donanemab approved and marketed as quickly as possible. Skovronsky said he believes the FDA feels a similar sense of urgency.

“Every day there are several patients who progress through this early stage of Alzheimer’s disease and do not benefit from treatment,” he said.

The FDA denied Lilly’s request for expedited approval of donanemab in January. The agency asked the company for more data on patients who had been treated for at least 12 months. , stating that there was no data at that time.

Lilly now plans to seek full FDA approval of donanemab. This will likely be covered by Medicare’s broader reach, which is important for access to patients, as most people who suffer from the disease are elderly.

Medicare is currently restricting access to Eisai and Biogen’s treatment Rekembi, an Alzheimer’s antibody treatment that received accelerated FDA approval for patients participating in clinical trials. based on the policy to

Leqembi delayed cognitive decline by 27% in patients with early Alzheimer’s disease.

The federal Centers for Medicare and Medicaid Services (CMS) has pledged to cover all patients with Alzheimer’s disease antibody treatments if they are fully approved. Biogen and Eisai said they hope to receive full FDA greenlight on July 6.

However, CMS will continue to require patient participation in registries that collect data on medicines. The Alzheimer’s Association said such registries continue to limit access to treatments and called on Medicare to remove those requirements.

Members of Congress and state attorneys general are also calling for Medicare to provide full and unrestricted coverage of FDA-approved Alzheimer’s antibody treatments.

Medicare enacted this policy following the June 2021 FDA approval of Biogen and Eisai’s antibody drug Aduhelm. The FDA quickly approved Aduhelm, over objections from an independent advisory panel that warned that the evidence did not show clear clinical benefit. .

Three members of the FDA advisory panel have resigned over the agency’s decision on Aduhelm.

A congressional inquiry found Aduhelm’s FDA approval to be “rife with irregularities.”