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U.S. purchases 1.7M courses of Merck's COVID-19 pill ahead of approval

U.S. purchases 1.7M courses of Merck's COVID-19 pill ahead
of approval 1

The Biden administration said Wednesday it will purchase 1.7 million courses of an investigational COVID-19 drug from pharmaceutical giant Merck that is taken orally and designed to prevent the virus from replicating in the body.

The Food and Drug Administration must approve molnupiravir (MK-4482) for emergency use before it can be wielded against the pandemic. Once granted, the drug will be allocated to states and territories so hospitals and clinics can order it from their nearest distributor.

A treatment in pill form would be a big leap forward in the fight against the coronavirus.

Almost half the U.S. hasn’t received any doses of a COVID-19 vaccine, so the virus may still afflict persons for months to come. Also, the vaccines are effective at preventing disease but not 100% perfect.

Merck developed the antiviral treatment with Ridgeback Biotherapeutics. The pill induces viral genome errors that make it hard for the coronavirus to copy itself in a patient.

The drug is designed to stave off hospitalization and death in patients who’ve had five days of symptoms or less and are at high risk of a bad outcome from the virus.

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Clinical trials to date showed promising results and a phase 3 trial is underway. It plans to enroll 1,850 patients globally with final data expected by the fall.

Studies suggest the drug may be effective against viruses such as influenza, Ebola and Venezuelan Equine Encephalitis virus, though the FDA hasn’t reviewed it for those uses.

The Biomedical Advanced Research and Development Authority and the Defense Department made the $1.2 billion purchase of 1.7 million five-day treatments of molnupiravir for use against COVID-19.

“In addition to this agreement with the U.S. government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfill Merck’s commitment to widespread access,” Merck President Rob Davis said.

Starting with the Trump administration’s “Operation Warp Speed,” the federal government has proactively fostered and purchases potential treatments against the coronavirus alongside vaccine development.

Merck initially worked on a vaccine but dropped the project after its candidate didn’t produce a robust immune response. It focused on its promising therapeutic instead.

Last year, the U.S. started using monoclonal antibody cocktails to stave off severe bouts of COVID-19.

One form of the groundbreaking drug appeared to help former President Trump recover from his infection, though doctors around the country said it was hard to stand up the treatment, which is given intravenously, for widespread use.

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