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US FDA approves Merck .’s home antiviral Covid-19 pill


On Thursday, the Food and Drug Administration authorized Merck’s Covid-19 antiviral pill for emergency use, adding another tool to the nation’s arsenal to combat the virus. virus again.

FDA’s move comes a day after the agency authorized it another antiviral, from Pfizer. The agency said Merck’s treatment, called molnupiravir and developed in partnership with Ridgeback Biotherapeutics, is approved for use in adults with mild to moderate Covid who are at increased risk of contracting the disease. seriously ill, the agency said in a statement. Pfizer’s drugs are approved for use by people under 12 years of age.

The big advantage of oral treatments, like Merck’s and Pfizer, is that they can be done at home and don’t require intravenous injections or injections. That could help the nation’s hospitals as new infections are expected to continue to rise this winter.

Clinical trials showed that the treatment reduced the risk of hospitalization and death by 30% in high-risk Covid patients.

By comparison, Pfizer’s drug has been shown to be 89 percent effective to prevent people at high risk of being hospitalized or dying from Covid. Pfizer’s ability to treat will be much more limited than Merck’s at first. That can pose a dilemma for doctors about which treatment options are best to refer to their patients.

USA Yes agree to buy about 3.1 million packages of Merck’s drugs for $2.2 billion. Jeff Zient, the White House’s Covid-19 response coordinator, said at a press conference on Wednesday that, if authorized, the majority of those treatments could be made available to states and jurisdictions. by the end of January.

An FDA advisory committee last month Vote closely in favor of the proposed treatment. The secret ballot reflects committee members’ concerns about both the drug’s effectiveness and safety, including possible risks to pregnant women and their unborn babies.

The FDA recommends that patients use birth control during treatment with Merck and for four days after the last dose.

According to the agency, potential side effects of the drug include diarrhea, nausea, and dizziness.

In a presentation to the advisory committee on November 30, the Merck scientists said they expect the drug to work against the omicron variant, which is currently the predominant variant in the United States. that’s because the strain contains mutations similar to other versions of the virus, although further testing is still needed, the company said at the time.

A full course of Merck treatment is a total of 40 pills, taken as four 200 mg pills, twice a day for five days. Patients should begin treatment within five days of the onset of symptoms. During the November advisory committee meeting, the drug manufacturer emphasized the importance of the patient ending the entire course of prescribed treatment.

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