First COVID treatment approved by FDA
Providence patients given remdesivir, under compassionate use
Last updated 11/4/2020 at 10:03am
COVID-19 now has an FDA approved anti-viral treatment for those hospitalized with the disease.
Veklury, generically named remdesivir, was cleared Oct. 22 by the FDA. It was authorized for compassionate use in the hospital setting for COVID prior to approval, with settings that include Providence in Everett.
Gilead's website states that 50 countries worldwide utilize the drug for COVID treatment. Today it becomes the first approved treatment for COVID-19.
Approved use includes adults as well as pediatric patients 12 years of age and older and at least 88 pounds. The pharmaceutical company Gilead invented the drug based on more than a decade of anti-viral research. Gilead claims the drug has "broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19," the company's website says.
Clinical trials assessing the safety and efficacy for the pediatric patient population are ongoing, the FDA states.
"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. 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."
Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence showing effectiveness and a demonstration of safety for the drug's intended treatments. The goal of clinical trials is to prove the product's benefits outweigh its risks.
The approval of remdesivir 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 of those studies, 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. That trial observed 1,062 hospitalized subjects with mild, moderate and severe COVID-19. Participants were either given the drug or a placebo, and continued to receive supportive care.
Recovery was defined as either being discharged from the hospital or being hospitalized without a need for supplemental oxygen, the FDA states. Patients were considered "recovered" if they no longer required ongoing medical care, the FDA states. The group given remdesivir recovered five days faster than the placebo group, which recovered in 15 days. Two other trials were considered as well.
The FDA press release on the approval is here: https://bit.ly/3ofbrEh
A full listing of clinical trials for COVID-19 are listed here: https://bit.ly/2Hq9xjF