FDA Approves First Drug for Treatment of COVID-19

Posted on by myMatrixx
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Gilead Sciences received full U.S. Food and Drug Administration (FDA) approval on Oct. 22, 2020, for Veklury® (remdesivir) injection. Remdesivir is to be marketed under brand name Veklury. Veklury is only available to hospitalized patients. Therefore, it will not impact any of our retail pharmacy formularies. Previously available only under an emergency use authorization (EUA), it is an antiviral drug approved to treat patients who are 12 years old or older, who weigh at least 40kg (88 pounds) and who are hospitalized with COVID-19 infections. After one 200mg dose on the first day of treatment, Veklury is administered over one-half hour to two hours at 100mg/day for adult patients. At the same time, the FDA revised an EUA for treating children under 12 years old who weigh at least 3.5kg (about eight pounds) and who are hospitalized with COVID-19. Pediatric patients must receive the lyophilized powder form of Veklury administered at a loading dose of 5mg/kg on day one followed by 2.5mg/kg per day. For all patients, treatment is continued for five days, but it may be extended up to a total of 10 days for patients who have not improved significantly after five days and for patients who need mechanical ventilation. Veklury will be dispensed only to hospitals; specialty pharmacies, including Accredo, will not have access. You can view a fact sheet on the pediatric EUA is here.

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