FDA takes steps to expand use of treatment to outpatients with mild to moderate COVID-19

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SILVER SPRING, MD., January 21, 2022 /PRNewswire/ — Today, the United States Food and Drug Administration took two steps to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adult and pediatric patients for the treatment of COVID-19 disease. 19 mild to moderate . This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.

“On the heels of the recent FDA clearance of two oral antiviral drugs, today’s actions strengthen the therapeutic arsenal to treat COVID-19 and respond to the rise of the omicron variant,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “Today’s actions provide adults and pediatric patients with mild to moderate COVID-19 who are at high risk for severe COVID-19 a treatment option they could receive outside of a facility. traditional hospital setting, including in skilled nursing facilities, home care facilities and ambulatory care facilities such as infusion centres.

Veklury is not a substitute for vaccination in people for whom vaccination against COVID-19 and a booster dose are recommended. The FDA has approved a vaccine and authorized others to prevent COVID-19 and the serious clinical consequences associated with COVID-19, including hospitalization and death. The FDA is urging the public to get vaccinated and receive a booster if eligible. Learn more about COVID-19 vaccines approved or cleared by the FDA.

The FDA has expanded the approved indication for Veklury to include its use in adults and pediatric patients (12 years and older who weigh at least 40 kilograms, or approximately 88 pounds) with positive SARS-CoV direct viral test results -2, and who are not hospitalized and who have mild to moderate COVID-19, and who are at high risk of progression to severe COVID-19, including hospitalization or death.

The agency also revised the Emergency Use Authorization (EUA) for Veklury to additionally authorize the drug for the treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients under 12 years of age weighing at least 3.5 kilograms, with positive SARS-CoV-2 direct viral test results, and who are not hospitalized and have mild to moderate COVID-19, and who are at high risk progression to severe COVID-19, including hospitalization or death.

Based on today’s actions, these high-risk outpatients may receive Veklury by intravenous infusion for a total of three days for the treatment of mild to moderate COVID-19 disease.

Approval of Veklury for use in non-hospitalized patients is supported by a randomized, placebo-controlled clinical trial that included 562 non-hospitalized patients with mild to moderate COVID-19 who were at high risk of progression to COVID-19. 19 severe, including hospitalization or death. The primary outcome measured in the trial was whether a patient was hospitalized for a COVID-19-related reason or died for any reason within 28 days of treatment. Overall, 2 of 279 patients who received Veklury (0.7%) required hospitalization related to COVID-19, compared to 15 of 283 patients who received placebo (5.3%). There were no deaths in either group.

Pediatric patients for whom Veklury is approved will receive doses adjusted according to their body weight to achieve exposures comparable to adults and pediatric patients receiving the approved dose. Given the similar course of COVID-19 disease, the authorization of Veklury in certain pediatric patients is based on extrapolation of efficacy from adequate and well-controlled studies in adults.

Important details about using Veklury to treat COVID-19 for its approved use are available in the prescribing information, which includes dosage instructions, potential side effects, and drug interactions. Possible side effects include increased levels of liver enzymes, which may be a sign of liver damage; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen levels, fever, shortness of breath, wheezing, swelling (for example, of the lips, around the eyes, under the skin), rash, nausea, sweating or chills. Similar safety information on the use of Veklury to treat COVID-19 in certain non-hospitalized pediatric patients in EUA is available in the information sheets for healthcare providers and parents/caregivers. .

The FDA granted its approval and reissued the revised EUA to Gilead Sciences Inc.

Additional Resources:

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Media Contact: Chanapa Tantibanchachai, 202-384-2219
Consumer requests: Email or 888-INFO-FDA (888-463-0332)

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.

SOURCE US Food and Drug Administration

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