FDA won’t grant accelerated OK to Alzheimer’s drug

Eli Lilly says agency needs safety data on more patients.

The Food and Drug Admin- istration is declining to grant accelerated approval to an experimental Alzheimer’s drug made by the pharmaceutical company Eli Lilly, saying the agency needs safety data on more patients, the company said Thursday.

The company said it received a “comp l ete response letter” from the FDA — a notice that outlines the agency’s reasons for declining to approve the drug application in its current form. Lilly officials said the agency wants to see safety data on at least 100 patients in clinical trials who have taken the drug continuously for at least 12 months.

Donanemab, an intrave- nous drug administered once a month for people with early symptoms of Alzheimer’s, is part of a small group of new treatments that in trials have been shown to slow the progression of the disease — not just treat its symptoms — by removing amyloid beta, a hallmark of the mind-rob- bing condition.

Lilly officials said they did not have 100 such patients in the mid-stage trial submitted to the FDA for accelerated approval because the drug cleared amyloid rapidly — sometimes in just six months. In those cases, the patients were taken off the drug and put on placebo, under the protocol of the trial.

The additional data will be provided by a large late- stage trial involving the drug that is expected to be completed in the second quarter of this year. That trial will be the foundation of the company’s application for traditional approval by the FDA, according to Lilly. The officials said the large, late-stage trial is their priority.

In a statement, the FDA said it could not disclose “the existence of, or information about, a pending application.”

The FDA action came as something of a surprise. Many analysts predicted the agency would clear the drug on an accelerated basis early this year. But even if the drug had received accelerated approval now, there would have been little access for patients because Medicare has sharply restricted coverage for anti-amyloid drugs approved on an accelerated basis by the FDA.

Company officials said the Fdadid not raise other issues and that they remained confident in the drug’s ability to clear amyloid and slow cognitive decline.

The treatment’s ability to rapidly remove amyloid beta “is a positive attribute” of the medicine, said Daniel M. Skovronsky, Lilly’s chief scientific and medical officer. Skovronsky said the hope, assuming the drug receives full approval, is that patients are able to receive the drug for a short time, get the amyloid cleared “and be done with their treatment.”

Two weeks ago, the FDA granted accelerated approval to Leqembi, another anti-amyloid drug for people in the early stages of Alzheimer’s that is made by Tokyo pharmaceutical company Eisai and its partner, Biogen, which is based in Cambridge, Mass.