Off to the examination of the anti covid pill. The European Medicines Agency Ema has started the rolling review procedure for the anti Covid pill molnupiravir. This was announced by Merck (MSD outside the US) and Ridgeback Biotherapeutics, American companies that are partners in the development of the experimental oral antiviral drug for the treatment of Sars-CoV-2 infection in adults.
Merck plans to collaborate with EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the cyclical review process, so as to facilitate the start of the formal evaluation of the authorization request on the market (Aic). The company recalls that it has also submitted an emergency use authorization application (Eua) to the US drug agency FDA, and that it is working to make requests to regulatory bodies around the world.
“This question to EMA is another step forward in our efforts to bring molnupiravir to patients around the world,” said Dean Y. Li, executive vice president and president of Merck Research Laboratories. “We believe molnupiravir will be an important addition to the range. of public health tools to fight Covid-19, including vaccines that remain essential and are the first line of defense against this pandemic “, he specifies.
“In the nearly 2 years since Covid-19 emerged – says Wendy Holman, CEO of Ridgeback – the global scientific community has made extraordinary progress in developing various vaccines and treatments, but we still need an oral antiviral drug that can be taken at home. We believe that molnupiravir, with the exciting evidence from the Move-Out study, reduced hospital admissions and deaths “by 50% among adult patients with mild to moderate Covid at increased risk of progression to severe disease of illness, “can help meet that need and we look forward to working with the EMA on its review”.
EMA – The launch of the rolling review was also confirmed by the EMA. The Committee for Medicinal Products for Human Use (Chpm) of the European Medicines Agency EMA has initiated the rolling review procedure on the oral antiviral molnupiravir (also known as MK 4482 or Lagevrio *), developed by Merck Sharp & Dohme (Msd, Merck in the USA) in collaboration with Ridgeback Biotherapeutics for the treatment of Covid-19 in adults. This was announced by the EMA, confirming the announcement by the American Merck on the start of the cyclical review by the EU regulatory body.
The decision of the CHMP – Committee for Medicinal Products for Human Use – to initiate the procedure is based on the preliminary results of preclinical and clinical studies. The data suggests that the pill may reduce the ability of the Sars-CoV-2 coronavirus to replicate, thus preventing hospitalization or death in Covid patients. The Agency will evaluate more data on the quality, safety and efficacy of the product, and the review will continue “until sufficient evidence is available to allow the company to submit a formal application for marketing authorization” (Aic), specifies the authority.
The Agency will assess the compliance of molnupiravir with the usual EU standards in terms of efficacy, safety and quality, adds the EMA. “Although” the regulatory body “cannot predict the overall timing – a note reads – it should take less time than normal to evaluate a possible Aic, due to the work done during the rolling review”.