Health Canada approves Veklury for treatment of COVID-19
New COVID drug approved
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 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 kilograms, 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 Gilead general manager Melissa Koomey. “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.
Gilead is working with the Public Health Agency of Canada and Health Canada to provide Veklury for Canadians over the coming weeks.
The drug 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.
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.
Veklury has received marketing authorization, pending the results of confirmatory trials to verify its clinical benefit.
This content was originally published here.