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EMA starts rolling review of Merck’s molnupiravir, continuing rapid regulatory response to COVID-19 antiviral data

October 25, 2021


Merck has opened another front in its campaign to get molnupiravir to market, kicking off a process that could lead to the approval of the oral COVID-19 antiviral in the EU.

Things have moved quickly since Merck and partner Ridgeback Biotherapeutics posted top-line data on molnupiravir in patients with mild to moderate COVID-19 at the start of the month. Merck got an application for approval to the FDA 10 days after reporting the data. Now, another two weeks down the line, the European Medicines Agency (EMA) has begun a rolling review of molnupiravir.

The EMA will use the rolling review to assess quality, safety and effectiveness data as they become available, continuing until Merck has enough evidence to file a marketing authorization application. It is unclear how long the rolling review or final assessment will take.

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