FDA Expands Emergency Use for Gilead’s Veklury to All Hospitalized COVID-19 Patients

The FDA has broadened the scope of an existing emergency-use authorization (EUA) for Gilead Sciences’ Veklury (remdesivir) to include treatment of all hospitalized adult and paediatric patients with suspected or laboratory-confirmed COVID-19, regardless of the severity of their disease. In May, the antiviral was authorized by the FDA for emergency use in adults and children with severe manifestations of COVID-19, after preliminary results from the phase 3 ACTT trial showed that it cut recovery times by an average of four days.

The expanded authorization “enables physicians to consider a broader range of eligible patients to potentially receive Veklury,” said Gilead Chief Mdical Officer Merdad Parsey. “As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease,” he added.

Aside from the ACTT trial, a separate study, dubbed SIMPLE, found that patients with moderate COVID-19 pneumonia who received a 5-day course of Veklury plus standard care were 65% more likely to achieve clinical improvement at day 11 based on a seven-point ordinal scale, compared to those given standard of care alone. However, the odds of improvement with a 10-day course of Gilead’s drug were not significantly different to standard care alone. The FDA noted that in this trial, mortality at day 28 was 2% or lower in all treatment groups. The SIMPLE study findings were recently published in JAMA.

Based on the agency’s “ongoing review of the EUA, including its review of the totality of scientific information now available…it is reasonable to believe Veklury may be effective for…all hospitalized adult and pediatric patients [with COVID-19],” the FDA said, adding it also “concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”

Veklury recently obtained conditional EU approval for use in adults and certain adolescents aged 12 years and older with pneumonia requiring supplemental oxygen.