Update on remdesivir: continued monitoring
Date published: November 26, 2020
The World Health Organization (WHO) is conditionally recommending that remdesivir not be used in patients with COVID-19, regardless of how severe the disease is. The WHO released its recommendation and guidelines on November 20, 2020.
Health Canada has reviewed the WHO considerations and recommendations. We are not making any immediate changes to the status of remdesivir in Canada at this time. Remdesivir will continue to be available as a treatment option for those with severe COVID-19 disease. Our position is the same as those of other major international regulators, such as the European Medicines Agency and the U.S. Food and Drug Administration.
Remdesivir was authorized with conditions in Canada on July 27, 2020. It was authorized for the treatment of severe COVID-19 in adults and youth (aged 12 years and over and weighing at least 40 kg) with pneumonia requiring supplemental oxygen. It was the first medication authorized specifically for the treatment of COVID-19, and remains one of the few approved therapies in Canada.
Health Canada’s authorization with conditions was based on the results of the ACTT-1 trial. This large randomized controlled trial was run by the U.S. National Institute for Allergy and Infectious Diseases (NIAID). Our authorization of remdesivir included conditions requiring the manufacturer to provide additional information on the drug’s performance, along with active safety monitoring of remdesivir.
The WHO notes that its analysis of the combined clinical trial data on remdesivir does not prove that remdesivir has no benefits for some patients. In developing its guidelines, the WHO also looked at the cost of remdesivir and its need to be administered intravenously.
Health Canada’s review takes into account our country’s health care system when assessing clinical trial data.
As part of Health Canada's authorization, the manufacturer Gilead Sciences Canada, Inc. must submit ongoing safety and effectiveness data for remdesivir. We are also waiting for the WHO to make available the full results of the Solidarity trial, which we will then evaluate.
We will continue to monitor and review all relevant data to determine whether changes to the market authorization of remdesivir in Canada are required.
For media inquiries, please contact Health Canada at 613-957-2983 or hc.media.sc@canada.ca.