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The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.
The European Medicines Agency announced on Nov. 8, 2021 that it will be reviewing data available on the use of molnupiravir (MK 4482 or Lagevrio) as a treatment for COVID-19 prior to authorization. A rolling review of the drug is currently ongoing. The agency’s Committee for Medicinal Products for Human Use (CHMP) will provide recommendations to national authorities in the European Union regarding the possibly early use of the medication. The decision came because of the rise in infections across the EU.
“EMA and HMA [Heads of Medicines Agencies] remain committed to expediting the evaluation of much needed COVID-19 treatments and vaccines, while ensuring these meet the EU’s high standards of safety and efficacy. EMA will communicate on the outcome of this review and that of the rolling review once they conclude,” the agency stated in a press release.
Molnupiravir, an oral antiviral medicine that reduces the ability of SARS-CoV-2 to multiply in the body, was developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics.