(CercleFinance.com) – Merck (MSD outside North America) and Ridgeback Biotherapeutics indicate that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization the Lagevrio market (molnupiravir).
The two pharmaceutical companies recall that this MA application concerns an indication of the product for the treatment of certain adults who have been diagnosed with Covid-19 in the European Union.
Believing that this recommendation ‘does not reflect the convincing data generated by the phase 3 MOVe-OUT trial and by real studies’, Merck and Ridgeback will appeal this decision and request a reconsideration of the CHMP opinion.
Lagevrio is approved or licensed in more than 25 countries, including Australia, Japan, the United States, the United Kingdom and China for the treatment of certain adults with Covid-19. It has been used in over four million patients worldwide.
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