Ronapreve approved by European Commission to treat non-hospitalised COVID-19 patients and for prophylaxis of the disease

Basel, 12 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has granted a marketing authorisation 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 ol der 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 (EMA) 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.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news