BRIEF—COVID-19 MAb Ronapreve gets EC nod

Swiss pharma giant Roche today announced that the European Commission has granted a marketing authorization for Ronapreve (casirivimab and imdevimab), for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe, and for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms (pre- or post-exposure prophylaxis).

This decision follows one day after the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), reflecting the EMA and the European Commission’s priority to shorten review timelines for safe, effective and high-quality therapeutics during the COVID-19 public health emergency, noted Roche.

Outside of the European Union, Ronapreve has been approved for use in Japan and conditionally in the UK and Australia, and is authorized for emergency or temporary pandemic use in additional territories, including the USA, India and Canada.