Pharmaceutical Services

COVID-19: EMA starts rolling review of molnupiravir

EMA’s human medicines committee (CHMP) has started a rolling review of the oral antiviral medicine molnupiravir (also known as MK-4482 or Lagevrio), developed by Merck Sharp & Dohme 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 hospitalisation or death in patients with COVID-19.

EMA will evaluate more data on the quality, safety and effectiveness of the medicine. The rolling review will continue until enough evidence is available for the company to submit a formal marketing authorisation application.

EMA will assess the compliance of molnupiravir with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

EMA will communicate further when a marketing authorisation application for the medicine has been submitted.

How is the medicine expected to work?

This medicine is an antiviral medicine which can be taken orally (by mouth). It is a ‘viral RNA polymerase inhibitor’, a medicine that interferes with the production of genetic material (RNA) of viruses. By interfering with the RNA production of SARS-CoV-2, molnupiravir is expected to prevent the virus from multiplying.

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