EMA Launches Rolling Review of Merck’s COVID-19 Antiviral

The European Medicines Agency (EMA) has begun evaluating Merck’s and Ridgeback Biotherapeutics’ COVID-19 oral antiviral, molnupiravir, in a rolling review of the data.

The decision to launch the real-time review process, which enables the EU regulator to assess data as soon as it becomes available, was based on positive phase 3 data suggesting the pill may reduce the ability of the SARS‑CoV‑2 virus to replicate and to reduce hospitalization and death rates.

In the U.S., an FDA advisory committee is set to consider molnupiravir on Nov. 30 and offer its recommendation on whether the available data support authorizing the drug for emergency use.