Merck Plans to Manufacture COVID-19 Antiviral Drug in Canada

Merck Canada announced Monday it plans to manufacture its oral antiviral COVID-19 drug in Canada, making the country a global hub for the production of the potentially game-changing treatment.

The drug company has invested $19 million to scale up production of its antiviral drug, molnupiravir, at Thermo Fisher Scientific’s facility in Whitby, Ont.

The drug — one of the first treatments for non-hospitalized COVID-19 patients — is currently pending Health Canada approval.  The antiviral works by blocking the enzyme essential for viral replication.

In its preliminary clinical trial results, Merck reported that its pill reduced the rate of hospitalization by 50 percent, compared to those who got a placebo pill. That was among patients who started taking the medication within five days of symptoms beginning.

But in an updated news release issued on Nov. 26, Merck said that data had come in from all participants and the relative risk reduction of hospitalization and death was actually lower, at 30 percent.

The updated data showed nine deaths in the placebo group, and one in the group that took molnupiravir.

Last week, Procurement Minister Filomena Tassi announced Canada had signed a deal to purchase 500,000 courses of the oral antiviral drug, with the option to purchase another 500,000, if Health Canada gives it the green light.

The news comes as U.S. federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration (FDA) posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice.

The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals.

Given those risks, the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases.

Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients.


This post is also available in: Tiếng Việt

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