Health Canada authorizes drug remdesivir for severe COVID-19 cases
Drug manufactured by Gilead Sciences Canada authorized with conditions
Health Canada has authorized, with conditions, the drug remdesivir for patients with severe COVID-19, though Canada's top doctor says the supply is limited.
The drug — which will go by the brand name Veklury — is manufactured by Gilead Sciences Canada.
On Tuesday, Health Canada announced the drug is now authorized for use in adults and adolescents age 12 and older, with a body weight of at least 40 kilograms.
The company did not seek permission to use the drug to treat pregnant women or children under 12.
In April, a study run 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 patients to recover by 31 per cent — 11 days on average versus 15 days for those just given usual care.
But Dr. Theresa Tam, chief public health officer of Canada, warned that "the supply with this company is very low globally."
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Remdesivir is administered intravenously and used only in health-care facilities where patients can be closely monitored.
"It's not something people can go out and access by themselves," Tam said Tuesday during a press conference.
Because the drug has been given an expedited review, the manufacturer will have to ensure the continued safety, efficacy and quality of the drug, a statement by Health Canada said.
Some already treated with drug
Remdesivir has also been granted emergency or conditional authorization in the U.S., 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 the drug will be expensive, Tam said that may be the case, but the price will be subject to "appropriate reviews."
"I am aware some of these drugs are going to cost a fair amount of money," Tam said. "We have to look at access, as well as what's a reasonable price."
Matthias Götte, professor and chair of the medical microbiology and immunology department at the University of Alberta in Edmonton, said the drug's approval is "excellent news."
"I guess there's no doubt this is really the the only antiviral agent with with a clear-cut advantage shown in the large clinical trial," he said.
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Götte explained that the drug targets what he calls "the engine of the virus."
"This is an enzyme that is absolutely required for replication of the virus, for spread and so forth. So if you target that engine, the virus cannot spread, cannot replicate."
With files from CBC's Karen Pauls and The Associated Press