FDA Approves First COVID Treatment, Gilead's Remdesivir Drug

The Food and Drug Administration on Thursday approved the first treatment for COVID-19, Gilead’s remdesivir for use in patients at least 12 years of age and weighing 88 pounds.

The antiviral drug, to be sold under the brand name Veklury, is for treatment only in hospitals or other healthcare settings that can render acute care.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen M. Hahn said, adding the agency is committed to getting treatments out as quickly as possible while assuring safety and efficacy.

The approval did not include the entire population authorized as part of an emergency use authorization issued May 1, the FDA noted.

The FDA said data from three randomized, controlled clinical trials indicated remdesivir was effective in mild to severe cases. In one trial of more than 1,000 subjects, patients given the drug recovered five days sooner than those given a placebo.

A second trial indicated nearly 400 patients who were treated for five or 10 days with the drug indicated those treated for five days improved more quickly than those treated for 10 days or those who received just standard care.

A third trial involving five days or 10 days of treatment indicated there was no difference in recovery or death rates between the two groups.

The drug’s possible side effects include: increased levels of liver enzymes, and allergic reactions, changes in blood pressure and heart rate, low blood oxygen levels, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.

President Donald Trump was given a five-day course of the drug after he was hospitalized for COVID-19 on Oct. 2.

COVID-19 has killed nearly 223,000 Americans since March.

Gilead (GILD) closed up 46 cents or 0.76% Thursday at $60.67.