Filenews 26 October 2021
The EMA's Committee for Medicinal Products for Human Use (CHMP) has launched a rolling review of the oral antiviral drug molnupiravir (also known as MK4482 or Lagevrio), developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics for the treatment of COVID-19 in adults.
How the drug is expected to act
This drug is an antiviral drug that can be taken orally. It is an "RNA virus polymerase inhibitor", a drug that interferes with the production of genetic material (RNA) of viruses. By interfering with the production of RNA of SARS-CoV-2, molnupiravir is expected to prevent the multiplication of the virus.
The CHMP's decision to initiate the rolling review is based on preliminary results of laboratory studies (non-clinical data) and clinical studies. These studies suggest that the drug can reduce the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body, thereby preventing hospitalization or death of COVID-19 patients.
The EMA will evaluate more data on the quality, safety and efficacy of the medicine. The rolling review will continue until sufficient data are available for the company to submit a formal application for marketing authorisation.
The EMA will assess the compliance of molnupiravir with the usual EU standards for effectiveness, safety and quality. Although the EMA cannot predict the overall timelines, it will take less time than usual to assess a potential application due to the work carried out during the rolling review.
The EMA will further inform when an application for marketing authorisation for the medicinal product is submitted.
What is a rolling review
The rolling review is a regulatory tool used by the EMA to accelerate the evaluation of a promising drug or vaccine during a public health emergency. Usually, all data on the efficacy, safety and quality of a medicine or vaccine and all required documents must be ready at the start of the evaluation, in an official application for marketing authorisation. In the case of the rolling review, the EMA's Committee for Medicinal Products for Human Use (CHMP) evaluates the data as they become available from current studies.
Once there is sufficient data, the company can submit a formal application.
By evaluating the data as they become available, the CHMP can give an opinion on the authorisation of the drug more quickly.
During the rolling review and throughout the pandemic, the EMA and its scientific committees are supported by the EMA's COVID-19 (COVID-ETF) Task Force. This group brings together experts from across the European Medicines Regulatory Network to advise on the development, authorisation and monitoring of the safety of medicines and vaccines for COVID-19 and facilitates swift and coordinated regulatory action.
