Gilead nabs conditional approval in Canada for Veklury to treat COVID-19 patients

29 July 2020

US biotech major Gilead Sciences (Nasdaq: GILD) says that Health Canada has issued a marketing authorization with conditions (Notice of Compliance with Conditions, or NOC/c) for Veklury (remdesivir).

Under this conditional authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents aged 12 years and older and weighing at least 40 kg, with pneumonia requiring supplemental oxygen.

Veklury has been studied in hospitalized COVID-19 patients spanning a wide range of disease severity. The conditional marketing authorization for Veklury is supported by the US National Institute of Allergy and Infectious Diseases' global Phase III trial of remdesivir (ACTT-1). Authorization in Canada was under the NOC/c guidance based on an acceptable safety profile and the promising nature of the efficacy of the treatment.

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