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FDA declines to give accelerated approval to Eli Lilly’s Alzheimer’s drug, firm says


The Food and Drug Administration 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 “complete 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 intravenous 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-robbing condition.

Lilly officials said in an interview 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 FDA 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 by patients because Medicare has sharply restricted coverage for anti-amyloid drugs approved on an accelerated basis by the FDA.

Company officials said the FDA did 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, in an interview. He 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.” Similar drugs have not been tested with an “end date” and experts wonder whether they will have to be taken for years.

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. The agency previously cleared the drug Aduhelm, which is made by the same two companies, but that treatment fizzled in the marketplace.

Eisai already has applied to the FDA for traditional approval for Leqembi — a likely prerequisite for broader coverage by Medicare, the federal health program for the elderly.

Lilly’s application for accelerated approval for its drug was based on data from a mid-stage clinical trial that showed donanemab sharply reduced amyloid beta and slowed cognitive decline by 32 percent over 18 months, compared with a placebo.

Leqembi was approved on data from a mid-stage trial that showed the drug knocked out amyloid beta. But, by a quirk of timing, Eisai and Biogen in November completed a larger, late-stage trial that showed the drug slowed progression of the disease by 27 percent over 18 months, compared with a placebo. That data, while too late to be the basis of the accelerated approval, undoubtedly provided some reassurance to regulators.

Leqembi’s clearance was greeted as a welcome advance by many doctors. Others said the therapy provides only a modest benefit and raises serious safety risks.

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