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Health Canada still reviewing data on antiviral COVID 19 drug approved in U.K.

November 4, 2021   by The Canadian Press

Health Canada says it’s “awaiting the final package of manufacturing data” on an antiviral COVID-19 drug that was authorized Thursday in the United Kingdom.

The federal regulator said it’s still reviewing information from the pharmaceutical company Merck after already receiving pre-clinical and clinical information on molnupiravir, considered the first pill to successfully treat COVID-19.

It offered no timeline for completion of the review process.

“A decision will be made once all of the required information has been submitted by the manufacturer and thoroughly evaluated by Health Canada,” the regulator stated by email.

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While molnupiravir was granted conditional authorization for use in Britain, it wasn’t immediately clear how quickly the pill would be available there.

Merck has been supplying data to Health Canada on a rolling basis since August, when the product was still undergoing clinical trials.

Health Canada says the review will determine whether benefits outweigh any risks and ensure the drug meets “stringent safety, efficacy and quality requirements.”

Merck announced preliminary results in September showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. The results haven’t yet been peer reviewed or published in a scientific journal.

The company also didn’t disclose details on molnupiravir’s side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.

The drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumours.

Britain’s Medicines and Healthcare products Regulatory Agency said molnupiravir’s ability to interact with DNA and cause mutations had been studied “extensively” and that it wasn’t found to pose a risk to humans.

Merck Canada said Thursday that Health Canada will decide on authorization after reviewing “all necessary evidence.”

The company added that a supply agreement was not yet in place but that conversations with the Canadian government were ongoing.

“We remain committed to working with the government to ensure Canadians will have access to our medicine should it receive market authorization by Health Canada,” Merck said in an email from its media centre.

Molnupiravir is also pending review with regulators in the United States, the European Union and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.

Merck and partner Ridgeback Biotherapeutic have requested clearance for the drug for adults with early cases of COVID-19 who are at risk for severe disease or hospitalization.

The pill was licensed in Britain for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug twice a day for five days.

Molnupiravir was initially studied as a potential flu therapy with funding from the U.S. government. Last year, researchers at Emory University decided to repurpose the drug as a potential COVID-19 treatment. They then licensed the drug to Ridgeback and partner Merck.