October 22, 2020
The U.S. FDA has approved Veklury® (remdesivir), manufactured by Gilead, to treat COVID-19 in patients who require hospitalization, are at least 12 years of age, and weigh at least 40kg (88 pounds). Under the approval, Veklury should only be used in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
In May 2020, Veklury received Emergency Use Authorization (EUA) from the FDA to treat certain patients diagnosed with COVID-19. Although not a formal FDA approval, the EUA helped to expand access to Veklury for patients who were not enrolled in clinical trials. The EUA was contingent upon Veklury demonstrating a potential for clinical benefits that outweighed the potential for adverse events in the face of a public health emergency. Full FDA approval was granted based on the data obtained in three clinical trials. In these trials, COVID-19 patients treated with Veklury were more likely to see an earlier improvement in their symptoms compared to those who received a placebo along with the current standard of care.
Recommended dosing with Veklury is a 200mg loading dose on Day 1 followed by once daily 100mg maintenance doses starting on Day 2. Veklury is administered via intravenous infusion over the course of 30-120 minutes. The duration of treatment is 5-10 days, based on patient response and whether the patient does or does not need either invasive mechanical ventilation or extracorporeal membrane oxygenation (a type of life support that oxygenates the patient’s blood outside of their body to allow the heart and lungs to rest).
Veklury is not recommended for patients who have severe renal impairment and has not been well studied in women who are pregnant. Although it is not currently FDA approved for use in children under the age of 12, it is currently being studied in this age group in clinical trials and has an EUA for use in this population.
Gilead has stated that it is currently meeting real-time demand for Veklury. The drug has a wholesale acquisition cost (WAC) of $520 per vial.