FILE - In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. (Gilead Sciences via AP)

Health Canada approves remdesivir for treatment of severe COVID-19

First drug authorized by the agency to treat the virus

Health Canada has authorized the use of drug remdesivir to treat severe symptoms of COVID-19, the agency said Tuesday (July 28).

The antiviral drug, manufactured by Gilead Sciences Canada, Inc., is the first treatment authorized for patients with serious symptoms of the virus in Canada. The drug is currently only approved for use in adults and teens aged 12 and up with a weight of at least 40 kilograms. It is not authorized for use in children or pregnant women, and is administered intravenously to treat patients with pneumonia requiring supplemental oxygen.

Canada is not the first to approve the use of remdesivir for COVID-19; the drug has been approved for use in U.S., Europe, Japan, Singapore and Australia. So far, the agency said a “small number” of patients are being treated with the drug under the Special Access Program, which will not be required for new patients going forward.

Health Canada said it completed an expedited six-week review to determine the drug’s benefits outweigh its risks when it comes to COVID-19. Two existing clinical trials are ongoing to evaluate the safety and efficacy of remdesivir. According to the European Medicines Agency, the most common side effect in healthy volunteers are increased blood levels of liver enzymes, and nausea in COVID-19 patients.

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@katslepian

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