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Friday, October 22, 2021

Health Canada working to review Merck’s experimental COVID-19 pill treatment

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TORONTO — Health Canada says it is working with international counterparts to review an experimental pill from drugmaker Merck, which the company reports can reduce hospitalizations and deaths by half in patients sick with COVID-19.

During a news briefing Friday, the Public Health Agency of Canada (PHAC) said Merck first submitted an approval request for molnupiravir, a twice-daily oral antiviral agent currently in trials, as a potential treatment for COVID-19 on Aug. 13.

According to PHAC, the submission was accepted under the Minister of Health’s Interim Order, which allows for the review of “early safety, quality and efficacy data” while later-stage clinical trials take place.

Canada’s chief medical adviser Dr. Supriya Sharma said review of the treatment is ongoing as more data from trials becomes available. Sharma said Health Canada will make an approval decision only when all necessary evidence has been submitted and reviewed.

“We are looking at it. We’re going through … the data,” she said.

Sharma said Health Canada has no specific time for completion of the review, but says the pill will be evaluated and “held to the standards” as any other medication or treatment.

According to Health Canada, it only authorizes treatments, including those for COVID-19, following a “thorough scientific review of the safety, efficacy and quality data.”

“A treatment must show evidence that it works well, is of high quality and is safe. The available data must demonstrate that the treatment’s benefits outweigh its risks,” the agency said in a statement.

Canada currently has four approved treatments for COVID-19, including Canadian-made COVID-19 monoclonal antibody bamlanivimab and antiviral medication remdesivir.

If cleared, molnupiravir would be the first oral pill shown to treat COVID-19.

Merck and its partner Ridgeback Biotherapeutics announced Friday that early results from its trials show that patients who received molnupiravir within five days of COVID-19 symptoms had about half the rate of hospitalization and death as those who received a placebo.

The study tracked 775 adults with mild-to-moderate COVID-19 who were considered to be at higher risk for severe disease because of health problems such as obesity, diabetes or heart disease.

The results were so strong that an independent group of medical experts monitoring the trial recommended stopping it early.

However, the results have not been reviewed by outside experts, which is the usual procedure for vetting new medical research.

Merck said it plans to submit the data in the coming days to health officials in the U.S. and other countries to authorize the pill’s use.

A decision from the U.S. Food and Drug Administration could come within weeks after that, and be distributed soon after.

With files from The Associated Press

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