Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
Roche announced that the European Commission has granted 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 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 (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.
“We welcome this quick approval from the European Commission, which adds to the growing number of health authorities that recognize Ronapreve as an important therapy for the treatment and prevention of Covid-19,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Although vaccinations are increasing globally, Europe is entering the fourth wave of rising cases and treatment options for the full range of disease severity and variants of concern are still needed. We look forward to working with additional global regulatory bodies as we continue to tackle Covid-19 together.”
Today’s decision from the European Commission is based on the EMA’s CHMP’s review of positive data from the REGN-COV 2067 treatment study in non-hospitalised patients and the REGN-COV 2069 prophylaxis study in people exposed to SARS-CoV-2 virus. Roche will continue to work with the EMA to potentially extend the marketing authorisation of Ronapreve to treat hospitalised patients with COVID-19.
EU marketing authorisation follows approvals in Japan, the United Kingdom and Australia