Health Canada has approved under certain conditions the remdésivir, marketed under the brand Veklury, to treat patients who have serious symptoms of COVID-19, for example patients who have pneumonia or are in need of extra oxygen to breathe.
“The remdésivir is the first drug approved by Health Canada for the treatment of the COVID-19,” said Health Canada statement on Tuesday.
This intravenous drug is manufactured by Gilead Sciences Canada.
The use of remdésivir has been approved for use in adults and youth 12 years of age or older who weigh at least 40 kg. It will be provided only in health facilities where patients can be closely monitored.
Health Canada has indicated that its approval was based on “an expedited review of six weeks of data known in the field of safety, efficacy, and quality to determine that the benefits of the drug outweigh its risks when used for approved indications”.
Since this is an expedited review, Health Canada will continue to analyze the data that will be provided by Gilead Sciences Canada on the impact of this drug on those who receive it, including pregnant women and patients with pre-existing liver problems or kidney.
The remdésivir could be approved quickly, thanks to a cooperation with other countries.
This drug also has received an emergency authorization, or conditional the United States, Europe, Japan, Singapore and Australia.
“We would like to thank Health Canada for conducting expedited review of the Veklury, given the urgent need to treat patients with the COVID-19 in Canada, said Melissa Koomey, general manager, Gilead Sciences Canada, by press release. We are grateful to him for his collaboration and his leadership as we combine our efforts to respond to this urgent public health.”