Late yesterday afternoon, the U.S. Food and Drug Administration announced its approval of the antiviral drug Veklury (remdesivir) from Gilead Sciences, Inc. It can now be used for adult and pediatric patients 12 years or older and weighing at least 88 pounds for the treatment of COVID-19 that requires hospitalization. According to the FDA, Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
Veklury is the first treatment for COVID-19 to receive FDA approval.
In their statement, the FDA stipulated that this approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, which included children under 12 and weighing less than 88 pounds. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.”
Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). In considering approval of a drug, the FDA conducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population. This is different from the standard used in the issuance of an EUA.
The approval of Veklury 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.
One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The trial looked at 1,062 hospitalized subjects with mild, moderate and severe COVID-19 who received Veklury or a placebo. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery was 10 days for the Veklury group compared to 15 days for the placebo group. Overall, the odds of clinical improvement at Day 15 were also statistically higher in the Veklury group when compared to the placebo group.
A second randomized, open-label multi-center clinical trial of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days and treatment for 10 days. Overall, the odds of a subject’s COVID-19 symptoms improving were significantly higher in the five-day Veklury group at Day 11 when compared to those receiving only standard of care. The odds of improvement with the 10-day treatment group when compared to those receiving only standard of care were numerically favorable, but not statistically significantly. A third study provided similar results.
The FDA also noted possible side effects could include increased levels of liver enzymes, which may be a sign of liver injury, and allergic reactions, which may include changes in blood pressure, heart rate, blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.
The FDA granted this application Fast Track and Priority Review designations. The Agency also granted this application a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats.