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Home Coronavirus

F.D.A. expands approval of remdesivir to patients who are not hospitalized.

January 22, 2022
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Friday’s approval by the Food and Drug Administration of remdesivir was expanded. This infused antiviral medication, Gilead Sciences, has been widely used in hospitals for Covid patients ever since the outbreak.

The drug is now approved for high risk Covid patients who do not need to be hospitalized. This is the same group that is eligible for monoclonal antibodies infusions and antiviral drugs, which are very limited.

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.

The increased approval of Remdesivir is unlikely to address widespread Covid shortages. This is due to its difficulty in administration. The treatment must be administered intravenously over three consecutive days, usually at a hospital or clinic. It is easy to administer intravenous infusions to patients who are in hospital. However, it is difficult to do so for patients who are sick at home. Omicron surge doctors are already overwhelmed and have indicated that the treatment is difficult to launch due to severe staff shortages.

Remdesivir, which was approved by the Covid in October 2020, attracted a lot of attention early in the pandemic. However, many experts began to doubt its effectiveness for hospitalized patients. The evidence supporting its use in patients early in their illness is stronger.

Remdesivir, according to clinical trials published in December, reduced the risk of death and hospitalization by 87 percent in high-risk Covid patients in Europe and the United States. It was given to these patients within seven days of the onset of symptoms. This was before Omicron variants were developed, but laboratory experiments have shown that remdesivir is still effective against Omicron.

Remdesivir can be ordered on the commercial market, unlike monoclonal antiviral antibodies and antiviral tablets, which are distributed to the states by the federal governments. The price per treatment course is $2,080 and includes the required dosage for non-hospitalized adults.

Remdesivir is a drug that Gilead sells under Veklury. It has been administered to more than 10,000,000 Covid patients. Gilead spoke on Friday. The company is conducting a safety study on a pill version of Remdesivir, which would avoid the difficulties associated with infusing it.

Source: NY Times

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