The FDA announced that it fully approved the use of remdesivir as a treatment for COVID-19 requiring hospitalization in all adult and some pediatric patients.
Remdesivir is only to be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care. The drug, also referred to by the FDA as Veklury, is the first treatment for COVID-19 to receive FDA approval, according to an FDA news release. It can be used for adult patients and pediatric patiens who are over 12 years old and weigh more than 40 kg (88 lb).
The drug was recently in the news after it was announced that it was among the treatments given to President Donald Trump during his bout with COVID-19.
Gilead Sciences (NSDQ:GILD) already had received FDA emergency use authorization for remdesivir, and now has approval and also received a revised EUA that authorized use of the drug for treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized patients less than 12 years old. There are ongoing clinical trials evaluating the safety and efficacy of remdesivir in this patient population.
Authorization for remdesivir came on the back of three separate randomized, controlled clinical trials, one of which found statistically significant clinical improvement, while the others saw favorable improvement that did not register as statistically significant.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Dr. Stephen M. Hahn said in the release. “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 to 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.”