• Wed. Oct 27th, 2021

Covid, Ema initiates review of monoclonal mixes to prevent disease


Oct 14, 2021

The European Medicines Agency Ema has started evaluating AstraZeneca’s monoclonal antibody mix that promises to prevent Covid-19. The CHMP Committee for Medicinal Products for Human Use – informs the EU regulatory body – has launched the continuous review (rolling review) on Evusheld * or AZD7442: a combination of the monoclonals tixagevimab and cilgavimab, in development for the prevention of Covid in adults. The decision of the CHMP is based on the preliminary results of clinical studies – recalls the EMA – which suggest the ability of the drug to protect against the disease caused by the Sars-CoV-2 coronavirus. The EU agency – a note reads – has begun examining preclinical data (obtained from laboratory and animal studies), and will analyze more information on the quality, safety and efficacy of the treatment as soon as it becomes available. The review will continue until there is sufficient evidence to allow the company to submit a formal application for marketing authorization. The EMA will assess Evusheld’s compliance with the usual EU standards for efficacy, safety and quality, the agency continues. And although the institution can accurately predict the time needed to approve the therapy, thanks to the rolling review mechanism it should take “less time than normal” to evaluate a possible go-ahead request.