EU regulator starts real-time review of Merck’s COVID-19 pill -Breaking
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© Reuters. FILE PHOTO: The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid(Reuters) – U.S. drugmaker Merck & Co Inc said on Monday the European Union’s drug regulator has initiated a real-time review of its experimental COVID-19 antiviral drug for adults.
The European Medicines Agency (EMA), also called a rolling review, would evaluate data immediately it is available instead of waiting to submit a formal request after all information has been gathered.
Merck’s innovative pill molnupiravir, which is primarily used to combat COVID-19 has been shown in studies that could halve or even eliminate the risk of serious illness.
Merck filed an emergency authorization application for U.S. use of the drug in October. It is being developed with Ridgeback Biotherapeutics and Merck. An advisory panel composed of experts from outside the U.S. government is meeting in November to decide whether the drug should be approved.
Molnupiravir, if it is cleared by regulators would be both the first COVID-19 oral drug and the first treatment for patients with mild to moderately severe illnesses. Existing drugs, however, are mostly prescribed to the severely ill.
According to the contract, the U.S. government will supply the drugmaker with 1.7 millions courses at $700 each course. The drugmaker also signed supply agreements with Singapore, Malaysia, and Britain recently.
Reuters received a statement from an EU official earlier in the month stating that it was considering signing a supply contract for the antiviral medication. But, this would be after approval has been obtained by the company.
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