Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir). Previously authorized only for emergency use (EUA) in the U.S., the drug can now be prescribed to adults and children 12 and older weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization.

Gilead said the medicine should only be administered in a hospital or comparable settings and that it is "now widely available in hospitals across the country." In July, Gilead set the government price of Veklury at $2,340 for a five-day treatment course in developed countries, though in the U.S. commercial insurers could pay more. For them, the company set a list price of $3,120 for the same five-day course, which is the recommended duration of treatment for patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO). Patients requiring invasive mechanical ventilation and/or ECMO are advised to receive the drug for 10 days.

Gilead said it "is now meeting real-time demand for Veklury in the United States and anticipates meeting global demand for Veklury in October, even in the event of potential future surges of COVID-19."

Veklury is an inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase, which is essential for viral replication. No clinical data are available on the development of SARS-CoV-2 resistance to the drug, according to its label. The FDA granted Gilead’s application both fast track status and a priority review.

The approval was based on three randomized controlled trials, including those of the U.S. National Institute of Allergy and Infectious Diseases' double-blind, placebo-controlled phase III ACTT-1 trial, which showed that "remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection."

Results of the SIMPLE-Severe trial, conducted in hospitalized patients who required supplemental oxygen and who were not mechanically ventilated, and the SIMPLE-Moderate trial, conducted in hospitalized patients who did not require supplemental oxygen, also supported the approval, Gilead said.

The Foster City, Calif.-based company did not make mention on Thursday of the recent release of interim data from the Solidarity Therapeutics Trial coordinated by the World Health Organization showing that Veklury, as well as hydroxychloroquine, lopinavir/ritonavir, and interferon regimens apparently "have little or no effect" on 28-day mortality or the in-hospital course of COVID-19 among patients admitted. Gilead did, however, dispute the rigor of review behind the Solidarity trial findings.

News of Veklury’s approval is likely to be a hot topic of conversation just hours from now when the most famous patient to receive the medicine, President Donald Trump, debates his Democratic rival, Vice President Joe Biden, during the third and final U.S. presidential debate.

In parallel with the FDA approval, the regulator also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients under 12 weighing at least 3.5 kg or weighing 3.5 kg to less than 40 kg with suspected or laboratory-confirmed COVID-19 for whom use of an I.V. agent is clinically appropriate.