Accessibility links

Breaking News

EU Drug Regulator to Expedite Authorization of Merck COVID Pill


FILE - An experimental COVID-19 treatment pill called molnupiravir being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters, May 17, 2021.

The European Union’s drug regulator, the European Medicines Agency, said Thursday it will accelerate its review of U.S. pharmaceutical company’s Merck’s COVID-19 pill — the same day Britain became the first nation to approve the oral treatment.

In a briefing with reporters from EMA headquarters in the Hague, Marco Cavaleri, EMA's head of vaccine strategy, could not yet give a timeline for final approval of the drug, known as molnupiravir. He said the agency was ready to give advice to individual EU member states so they can make the pill available for emergency use ahead of the EMA authorization.

EMA made the announcement as the World Health Organization’s European regional director said Europe, with its surging cases of COVID-19, is now the epicenter of the pandemic.

Earlier Thursday, Britain’s Medicines and Healthcare products Regulatory Agency approved the oral treatment.

Britain’s Health and Social Care Secretary Sajid Javid called it a “historic day” for the country, as the first nation to approve an antiviral drug that can dispensed by a pharmacy taken at home to treat COVID-19. Previously, treatments could only be administered through an intravenous drip.

In the United States, the Food and Drug Administration and the Centers for Disease Control and Prevention are not scheduled to consider the drug for approval until late November.

Last month, when Merck first offered the drug for review, White House coronavirus response coordinator Jeff Zients said the U.S. government already had arranged to buy 1.7 million doses of the pill, with an option for more if needed.

Some information in this report came from the Associated Press and Reuters.