CHMP initiates rolling review of molnupiravir for COVID-19

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of the oral antiviral medicine molnupiravir, also known as MK 4482 or Lagevrio, for the treatment of COVID-19 in adults. Molnupiravir is an investigational oral antiviral developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics for the treatment of severe COVID-19.

A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. In the case of a rolling review, CHMP reviews data as they become available from ongoing studies. Once sufficient data are available, the company can submit a formal application. By reviewing the data as they become available, the CHMP can come to an opinion on the medicine’s authorisation sooner. 

During the rolling review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force (COVID-ETF) which brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19, and facilitate quick and coordinated regulatory action.

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

The European Medicines Agency (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.

The Agency 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 stated that it will communicate further when a marketing authorisation application for the medicine has been submitted.