Canadian Manufacturing

Health Canada grants marketing authorization for Gilead’s treatment of COVID-19

Veklury is the first approved treatment option for COVID-19 in Canada

July 29, 2020  by CM Staff

Veklury (remdesivir) vial (PHOTO: Gilead Sciences Canada, Inc.)

MISSISSAUGA — Gilead Sciences Canada, Inc., a research-based biopharmaceutical company, announced that Health Canada has issued a marketing authorization for Veklury (remdesivir), a nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens.

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.

“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, in a prepared statement. “We are thankful for their collaboration and leadership, as we together work to respond to this public health emergency.”

According to the announcement, Veklury has been studied in hospitalized COVID-19 patients.

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Gilead is working with the Public Health Agency of Canada (PHAC) and Health Canada to provide Veklury for Canadians over the coming weeks, according to the statement.