EMA starts rolling review of molnupiravir

The European Medicines Agency’s human medicines committee (CHMP) has started a rolling review of the oral antiviral medicine molnupiravir (also known as MK‑4482 or under the trade name Lagevrio), developed by Merck & Co (NYSE: MRK), known as MSD outside of North America, in collaboration with Ridgeback Biotherapeutics, for the treatment of COVID‑19 in adults.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies. These studies suggest that the medicine may reduce the ability of SARS‑CoV‑2 (the virus that causes COVID‑19) to multiply in the body, thereby preventing hospitalization or death in patients with COVID‑19.

Merck hit the headlines earlier this month, when it announced that interim Phase III results with molnupiravir showed that the investigational antiviral pill significantly reduced the risk of hospitalization or death in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19.