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FDA Approves Remdesivir As First Drug Specifically to Treat COVID-19

The first drug has been approved by the FDA to treat COVID-19. Find out what research lead to the approval of remdesivir with significant limitations on how and where the medication can be used. Also at issue is how approval affects use of the drug under previous emergency use authorization.

WASHINGTON, DC – For the first time, U.S. Food and Drug Administration has approved a medication specifically for treating COVID-19.

Approved was the antiviral remdesivir, marketed as Veklury, for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. The FDA emphasizes that remdesivir should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

Interestingly, the entire population authorized to use remdesivir under an Emergency Use Authorization (EUA) originally issued on May 1, 2020, is not included in the approval. FDA officials explained, however, that to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised that authorization to allow the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. An FDA press release also says that clinical trials assessing the safety and efficacy of Veklury in the 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, MD. “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. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

In contrast to the standard used to issue an EUA, with 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. In this case, data was considered from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. One showed significantly higher odds of clinical improvement by Day 15, another should numerically favorable results, although not statistically significant, and the third compared remdesivir dosages.

FDA officials advised that possible side effects of treatment with the antiviral include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.

The application was granted under FDA’s Fast Track and Priority Review designations. It also was under the 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. 

At the same time, the FDA granted approval and reissued the revised EUA to Gilead Sciences Inc.