The company has not sought permission to use the drug to treat pregnant women or children under 12.
In April, a study by the U.S. National Institutes of Health tested remdesivir versus usual care in 1,063 hospitalized coronavirus patients around the world. It found that the drug reduced the time it takes for patients to recover by 31% – 11 days on average compared to 15 days for those who have just received usual care.
But Dr. Theresa Tam, Canada’s chief public health officer, warned that “this company’s supply is very low globally.”
WATCH | United States purchases global supply of remdesivir:
Remdesivir is administered intravenously and used only in healthcare facilities where patients can be closely monitored.
“It’s not something that people can go out and access on their own,” Tam said Tuesday at a press conference.
Since the drug has undergone an expedited review, the manufacturer will need to ensure the continued safety, efficacy and quality of the drug, according to a Health Canada release.
Some already treated with drugs
Remdesivir has also obtained emergency or conditional clearance in the United States, Europe, Australia, Singapore and Japan.
In Canada, a small number of patients have been or are being treated with the drug under the Special Access Program.
Asked about reports that the drug is costly, Tam said it may be, but the price will be subject to “proper scrutiny.”
“I’m aware that some of these drugs are going to cost a considerable amount,” Tam said. “We need to look at access, as well as what a reasonable price is. ”
Matthias Götte, professor and chair of the Department of Medical Microbiology and Immunology at the University of Alberta in Edmonton, said approval of the drug was “great news”.
“I guess there’s no question that this is really the only antiviral agent with a clear benefit shown in the large clinical trial,” he said.
Götte explained that the drug targets what he calls “the engine of the virus”.
“It is an enzyme which is absolutely necessary for the replication of the virus, for its propagation and so on. So if you target this engine, the virus cannot spread, cannot replicate. “