Health Canada has authorized a new drug for the treatment of COVID-19 in adults and adolescents with pneumonia who require supplemental oxygen.
In a release, Gilead Sciences Canada, Inc. announced that Health Canada issued a marketing authorization with conditions (Notice of Compliance with Conditions, or NOC/c) for Veklury® (remdesivir).
Under the 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.
"We appreciate Health Canada's expedited review of Veklury in recognition of the urgent need to treat COVID-19 patients in Canada," said Melissa Koomey, General Manager, Gilead Sciences Canada. "We are thankful for their collaboration and leadership, as we together work to respond to this public health emergency."
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 U.S. National Institute of Allergy and Infectious Diseases' global Phase 3 trial of remdesivir (ACTT-1)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.
Gilead is working with the Public Health Agency of Canada (PHAC) and Health Canada to provide Veklury for Canadians over the coming weeks.
Photo: Gilead Sciences Canada, Inc.About Veklury
Veklury (remdesivir) is a nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of remdesivir for the treatment of SARS-CoV-2, the virus that causes COVID-19. In recognition of the current public health emergency and based on available clinical data, remdesivir has been approved as a treatment for patients with severe COVID-19 in Japan, Taiwan, Hong Kong, India, Singapore, Australia, the United Arab Emirates and the European Union. Outside of these regions, remdesivir is an investigational, unapproved drug.
Veklury has received marketing authorization under the NOC/c policy for its indicated uses, pending the results of confirmatory trials to verify its clinical benefit. Patients should be advised of the nature of this authorization.
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