FDA approves first treatment for COVID-19

On October 22, FDA approved remdesivir (Veklury—Gilead Sciences) for the treatment of hospitalized COVID-19 patients aged 12 years and older weighing at least 40 kilograms (about 88 lbs). This is the first treatment for COVID-19 to receive FDA approval.

The agency first issued an emergency use authorization (EUA) for the antiviral drug in May. FDA said that it has revised the EUA for remdesivir to authorize the drug's use for the 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. "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."

The approval of remdesivir is based on three randomized, controlled clinical trials involving patients hospitalized with mild-to-severe COVID-19. The ACTT-1 trial, conducted by the National Institute of Allergy and Infectious Diseases, found that hospitalized patients with COVID-19 who received remdesivir recovered faster, on average, than those who received placebo (10 days vs. 15 days). The second trial involved hospitalized adults with moderate COVID-19 and compared 5-day and 10-day dosing with remdesivir with standard of care, while the third trial evaluated 5-day and 10-day treatment with remdesivir in hospitalized adults with severe COVID-19.

FDA said that possible adverse effects associated with the drug 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, rash, nausea, sweating, or shivering.

FDA granted this application Fast Track and Priority Review designations. It also granted the 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.