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Canada authorizes first drug to treat ‘severe’ COVID-19

Tuesday, July 28, 2020 @ 1:47 PM | By Terry Davidson


Health Canada has for the first time authorized a drug to treat COVID-19.

According to a July 28 news release, the federal government’s health regulator “has authorized with conditions the drug remdesivir (brand name Veklury) … for the treatment of patients with severe symptoms of COVID-19.”

The drug, which is made by Gilead Sciences Canada Inc., will be given to those with pneumonia and who require extra oxygen.

It is administered intravenously and will be used only in health-care facilities. It has been authorized for use in both adults and adolescents 12 and older, provided they weigh at least 40 kilograms.

The release notes that Gilead Sciences “did not seek authorization for an indication for use of remdesivir to treat children or pregnant women.”

Until now, a small number of patients in Canada were being treated with remdesivir under the Special Access Program. With authorization, the program will no longer be required in order to receive the drug.  

“Remdesivir is the first drug that Health Canada has authorized for the treatment of COVID-19,” the release states.

The authorization of the drug comes with conditions, including that Gilead Sciences ensure continued “safety, efficacy and quality”; that it submit “post-market” safety monitoring reports; and that it hand over “quality data” demonstrating that the manufacturing “processes and controls” are consistently producing a drug “of suitable quality for the intended use.”

The drug’s authorization comes after an “expedited six-week review” of data around safety and effectiveness.

The release notes that remdesivir “has also been granted emergency or conditional authorization in the [United States], Europe, Japan, Singapore and Australia.”

“In Canada, the authorization included a full scientific review,” it states.

It notes that two existing clinical trials will continue in order to “gather more data on the drug.”

As of July 27, there were 114,597 cases of COVID-19 in Canada. As of then, almost 9,000 had died as a result of the virus.

If you have any information, story ideas or news tips for The Lawyer’s Daily, please contact Terry Davidson at t.davidson@lexisnexis.ca or call 905-415-5899.