F.D.A. Approves Remdesivir for Patients Not Hospitalized

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The Food and Drug Administration on Friday expanded the approval of remdesivir, the infused antiviral medication from Gilead Sciences that has been widely used for hospitalized Covid patients since the early days the pandemic.

The drug is now also approved for high-risk Covid patients who are not sick enough to be hospitalized. That is the same group of patients that are eligible for monoclonal antibody infusions and antiviral pills, which are in very short supply.

While a limited number of hospitals and clinics have already been administering remdesivir to non-hospitalized patients on an off-label basis, the agency’s move may encourage more doctors to consider the drug for these patients.

Still, the expanded approval of remdesivir is not likely to alleviate widespread Covid treatment shortages, in large part because it is difficult to administer. The treatment must be given via intravenous infusion over three consecutive days, generally at a hospital or clinic. That is easy enough for patients who are hospitalized, but much harder to do for medically vulnerable patients who are ill and at home. Doctors who are already overwhelmed by the Omicron surge have said the treatment is difficult to launch amid widespread staffing shortages.

Remdesivir, which in October 2020 became the first Covid treatment to win full approval, generated intense interest early in the pandemic, but many experts grew skeptical of its benefits for hospitalized patients. The data supporting its use in patients earlier in their illness are stronger.

In clinical trial results published in December, remdesivir was found to reduce the risk of hospitalization and death by 87 percent when given to unvaccinated, high-risk Covid patients in the United States and Europe within seven days of the start of symptoms. That study was conducted before the emergence of the Delta and Omicron variants, but remdesivir has been found in laboratory experiments to remain potent against Omicron.

Unlike monoclonal antibodies and antiviral pills, which are distributed to states by the federal government, remdesivir is available for ordering on the commercial market. The drug is priced at $2,080 per treatment course at the dosage required for non-hospitalized adults.

Remdesivir, which Gilead sells under the brand name Veklury, has been given to more than 10 million Covid patients, Gilead said on Friday. The company is starting a safety study of a pill form of remdesivir that would sidestep the challenges created by having to infuse it.



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