The EMA begins its review of a new antiviral drug for treating COVID-19 in adults
The European Medicines Agency (EMA) has started a rolling review of a new oral antiviral medicine (molnupiravir) for the treatment of COVID-19 in adults.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has taken the decision to start the rolling review based on preliminary results from non-clinical and clinical studies, which suggest that the drug (also known as MK-4482) may reduce the ability of SARS-CoV-2 to multiply in the body, thereby preventing hospitalisation or death in patients with COVID-19.
The treatment has been developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics.
The CHMP will evaluate more data on the quality, safety, and efficacy of the medicine as they become available. The rolling review will continue until enough evidence is available for the company to submit a formal marketing authorisation application.
The EMA will assess the compliance of molnupiravir with EU standards for efficacy, safety, and quality. While the overall timelines cannot be predicted at this point, they expect that the approval of a licensing application will take less time than usual because of the work done during the rolling review.
This news comes in light of news that the UK Government has announced deals to secure two new antivirals, molnupiravir and PF-07321332/ritonavir, for the treatment of COVID-19.
This article originally appeared on Univadis, part of the Medscape Professional Network.
You can also find our clinical summaries relating to COVID-19 here.
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