FDA Approves Veklury for Treatment of COVID-19 Patients Who Meet Certain Criteria

As reported in an October 22 press release, the U.S. Food and Drug Administration (FDA) has approved the antiviral drug remdesivir, sold as Veklury, to treat COVID-19 patients who meet specific criteria. The authorization, according to the agency, permits use of the medication for infected patients who are hospitalized, 12 years of age and older and weigh at least 40 kilograms (about 88 pounds). Additionally, Veklury must be administered via intravenous infusion in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.” The FDA notes this approval differs from the Emergency Use Authorization issued for Veklury in May because it does not include the entire population.

The approval of Veklury, says the release, “was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.” Based on results cited in the FDA statement, the medication is shown to be effective in reducing the median recovery time for patients infected with the virus. FDA Commissioner Stephen Hahn explains that this approval reflects the agency’s commitment “to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency.”

Policyholders are encouraged to review the full prescribing information for detailed guidance on indications, usage, dosage, administration, precautions and potential adverse reactions.

MLMIC has assembled a number of critical resources to support New York physicians as they care for patients during the pandemic, including:

• NIHR Identifies Four Syndromes Commonly Experienced by Patients With “Long COVID,” a blog post on four common syndromes impacting patients with ‘long COVID;”
• Experts Say a COVID-19 Infection May Result in Lasting Health Consequences, a blog post on the long-term health consequences impacting a growing number of patients infected with COVID-19; and
• New Prediction Model Can Help Forecast Severity of COVID-19, a blog post on a new prediction model capable of helping healthcare systems care for COVID-19 patients and make important decisions about planning and resource allocations.