Filenews 25 October 2021
The launch of an accelerated evaluation process of the antiviral drug molnupiravir of the American company Merck (in Europe known as MSD) for the treatment of the coronavirus in adults, the European Medicines Agency (EMA) announced on Monday.
The new drug, also known as MK 4482 or Lagevrio, is in the form of a pill taken orally and was developed in collaboration with the company Ridgeback Biotherapeutics.
The EMA's Committee for Medicinal Products for Human Use (CHMP) has decided to approve the launch of the rolling evaluation on the basis of preliminary results of laboratory studies and clinical trials.
According to the announcement, preliminary results show that the drug "may limit the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body, thus preventing hospitalization and the death of patients infected with Covid-19."
As noted, the EMA will examine data concerning the quality, safety and efficacy of the drug, until enough data are gathered for the company to submit an official application for its placing on the European market.
The EMA clarifies that although it cannot be reported on an exact timeline, a possible application will be considered more quickly if it is submitted due to the work done in the preliminary rolling evaluation phase.
