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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 on a sign at 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.

This procedure is also known as a rolling review. The European Medicines Agency would instead assess the data when it became available than waiting until a formal application has been made after the required information had been gathered.

Although vaccines remain the best weapon against COVID-19 and are essential, Merck’s new experimental pill molnupiravir from Merck could prove to be a breakthrough. Studies have shown that it can reduce the chance of death or hospitalisation for people most vulnerable to severe illnesses.

Merck and Ridgeback Biotherapeutics are developing Molnupiravir together. On Oct. 11, Merck applied for U.S. Emergency Use Authorization for the drug. The panel of U.S. regulators’ outside advisors is scheduled to meet in November for a discussion about authorizing the antiviral experimental pill.

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.

A contract was signed by the U.S. government for the supply of 1.7 million units of the drug. The cost per unit is $700. 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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