Health Canada has authorized with conditions the drug remdesivir (brand name Veklury) manufactured by Gilead Sciences Canada, Inc. for the treatment of patients with severe symptoms of COVID-19 who have pneumonia and require extra oxygen to help them breathe.
Remdesivir is the first drug that Health Canada has authorized for the treatment of COVID-19.
Remdesivir is authorized for use in adults and adolescents (aged 12 years and older with a body weight of at least 40 kg). Gilead Sciences Canada, Inc. did not seek authorization for an indication for use of remdesivir to treat children or pregnant women.
The Department has approved this drug with conditions for the manufacturer to ensure the continued safety, efficacy and quality of the drug. Remdesivir is administered intravenously and will be used only in healthcare facilities where patients can be closely monitored. As well, the manufacturer (Gilead Sciences Canada, Inc.) will submit to Health Canada:
- post-market safety monitoring reports, as well as reports on all serious adverse drug reactions, annual pregnancy safety reports and any foreign regulatory actions related to the safety of remdesivir;
- any further data on the safety and efficacy of the drug, including final data from ongoing clinical trials and additional safety data on patients with liver and kidney disease; and
- further quality data confirming that the manufacturing processes and controls will consistently produce product of suitable quality for the intended use.
Health Canada will continue to closely monitor the safety of remdesivir in Canada and will take prompt action should any safety concerns arise.
The Department completed an expedited six-week review of the available safety, efficacy and quality data to determine that the drug’s benefits outweigh its risks when used for the authorized indication. This expedited review was made possible in part through international regulatory cooperation with comparable regulators.
Remdesivir has also been granted emergency or conditional authorization in the U.S., Europe, Japan, Singapore and Australia. In Canada, the authorization included a full scientific review. There is no preset expiry date on the authorization.
With the authorization of remdesivir, the Special Access Program will no longer be required to access the drug. Two existing clinical trials authorized by Health Canada to evaluate the safety and effectiveness of remdesivir for use in Canada are ongoing. These clinical trials will continue to gather more data on the drug.
The Public Health Agency of Canada is continuing to lead work with Gilead Sciences Canada, Inc. to secure access to remdesivir for Canadians.
SOURCE: Health Canada