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CHMP建议批准Ronapreve用于预防和治疗COVID-19

Author: Medicalhalo
Release time: 2025-10-19 11:44:20
According to the latest statistics from the World Health Organization, new COVID-19 deaths are showing a downward trend in all parts of the world, with only Europe still increasing. At present, significant progress has been made in the research and development of a number of specific COVID-19 drugs around the world, taking another step forward in successfully fighting the epidemic. Monupivir, the first oral drug for COVID-19, has been launched, and other treatments to treat or prevent COVID-19 are also being actively developed.

On November 11, 2021, Roche announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the antibody combination Ronapreve™ (casirivimab and imdevimab) for the treatment of patients without supplementation. For use in oxygenated persons with COVID-19 who are at increased risk of disease progression (adults and adolescents 12 years and older and weighing at least 40 kg); and for the prevention of COVID-19 infection in persons 12 years and older and weighing at least 40 kg (pre- or post-exposure prophylaxis). The European Commission is expected to make a final decision on the approval of Ronapreve soon.

(Source: Internet)

Dr. Levi Garraway, chief medical officer and head of global product development at Roche, said: "As cases surge in Europe, people must take different approaches in addition to vaccination to reduce the burden of the disease. Ronapreve has proven efficacy in treating and preventing COVID-19 and against various mutant strains. Earlier this year, people infected with COVID-19 across Europe were already treated with Ronapreve under emergency authorization based on the scientific opinion of the CHMP, and we are pleased that the Commission has now recommended approval of this antibody combination."
In February 2021, EMA's CHMP launched a rolling review of Ronapreve, a regulatory tool used to speed up the evaluation of promising medicines during public health emergencies. This recommendation is based on positive data from the REGN-COV 2067 treatment study in non-hospitalized patients and the REGN-COV 2069 prevention study in people exposed to the SARS-CoV-2 virus.
During this extraordinary time, Roche stands with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic.
References:
https://www.roche.com/media/releases/med-cor-2021-11-11.htm

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