Molnupiravir experimental drug (Ansa)
Anti-Covid pill: Merck asks FDA for authorization
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October 25, 2021 The Committee for Medicinal Products for Human Use (CHPM) of the European Medicines Agency EMA has initiated the rolling review procedure on the oral antiviral molnupiravir (also known as MK 4482 or Lagevrio) for the treatment of Covid -19 in adults and developed by Merck Sharp & Dohme (Msd, Merck in the USA) in collaboration with Ridgeback Biotherapeutics.
This was announced by the EMA, confirming the announcement by the American Merck on the start of the cyclical review by the EU regulatory body.
The decision of the CHMP - explains the EMA - is based on the preliminary results of preclinical and clinical studies. The data suggests that the pill may reduce the ability of the Sars-CoV-2 coronavirus to replicate, thus preventing hospitalization or death in Covid patients.
The Agency will evaluate more data on the quality, safety and efficacy of the product, and the review will continue "until sufficient evidence is available to allow the company to submit a formal application for marketing authorization" (Aic), specifies the authority.
The Agency will assess the compliance of molnupiravir with the usual EU standards in terms of efficacy, safety and quality, adds the EMA.
"Although" the regulatory body "cannot predict the overall timing - a note reads - it should take less time than normal to evaluate a possible Aic, due to the work done during the rolling review".