Federal government no longer controlling key COVID-19 drug

Hospitals can order a coronavirus treatment directly from its maker and distributor instead of relying on the government as a go-between, the Trump administration announced Thursday, saying supply of the drug exceeds demand.

Remdesivir, sold by Gilead Sciences under the brand name Veklury, is one of several therapies being wielded against the coronavirus and will remain a key tool after a vaccine is approved.

The U.S. government bought much of the supply of remdesivir in June after clinical trials suggested it could help COVID-19 patients recover faster. Federal officials wanted to lock down the drug for Americans during the scramble to get the pandemic under control. The number of cases has generally declined across the country after a midsummer Sun Belt spike, though some worry spots remain.

“Federal government oversight of the allocation of Veklury is not required because the drug is no longer a scarce resource — a tribute to progress we have made against COVID-19 and to the strength of our partnerships with the private sector,” said Health and Human Services Secretary Alex M. Azar II.

Johanna Mercier, chief commercial officer at Gilead Sciences, said there is “enough supply on hand to treat every existing COVID hospitalization in the U.S.”

She said they’re also confident they can meet demand even if the disease surges.

The Food and Drug Administration hasn’t fully approved a treatment for COVID-19, though remdesivir is part of an expanding arsenal of drugs with emergency or temporary authorization for use on patients.

A steroid, dexamethasone, has been shown to help some patients survive, and companies are reporting positive results from trials of synthetically produced proteins known as “monoclonal antibodies.”

Scientists say therapies will remain a key part of the response for the foreseeable future. Efforts to inoculate the American public will stretch into 2021 and the eventual vaccine will not be 100% protective, so doctors will rely on groundbreaking treatments to keep people out of the hospital or recover faster.

“There’s two issues — no vaccine works perfectly in everyone. Secondly, there will be some people who don’t end up getting the vaccine or are infected before they are able to get vaccinated,” said Dr. John Redd, assistant health secretary for preparedness and response.

The seven-day rolling average of coronavirus cases in the U.S. is up to 43,000 per day compared to roughly 35,000 three weeks ago, according to a New York Times tracker.

That’s better than the 66,000 per day recorded in mid-July, though worse than the 20,000 or so around late May. Transmission appears to be surging in Midwest states — notably Wisconsin, where President Trump plans to hold rallies on Saturday.

“The president believes that people have a First Amendment right to political speech. He is having a rally, people can choose whether or not to come,” said White House press secretary Kayleigh McEnany.

Mr. Trump loves to highlight the immediate power of therapeutics in fighting the virus, placing them roughly on par with a vaccine as he boasts about the declining case-fatality rate in the U.S.

“I want something that’s going to make people better, that people aren’t going to get sick with. That includes therapeutics, where we’re doing equally as well. Therapeutics,” he told reporters last month.

Regeneron Pharmaceuticals, of Tarrytown, New York, on Tuesday said early data from a randomized trial of its “cocktail” of monoclonal antibodies reduced viral load and the time needed to alleviate symptoms in non-hospitalized patients with COVID-19.

“The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally occurring immune response,” said George D. Yancopoulos, president and chief scientific officer at Regeneron.

The administration made 500,000 doses of remdesivir available to states and territories between July and September.

Dr. Redd said localities and hospitals had not been accepting or needing the full allocation made available to them, so the government no longer needed to be involved.

“We see this as a very good sign, and it’s been a key indicator that supply of remdesivir now outweighs demand,” Dr. Redd said.

Officials said AmerisourceBergen will remain the sole distributor of drug through the end of the year, and the price of the drug will not change. It will still be Gilead’s wholesale acquisition price — $3,2000 per treatment course, or $520 per vial.

Patients generally do not pay directly for hospital-administered drugs such as remdesivir, since the costs are rolled into overall treatment costs paid by Medicare or private insurers.

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