Ronapreve Approved by European Commission for Treatment and Post-Exposure Prophylaxis of COVID-19 Amid Global Cases Surpassing 253 Million
Nov 14, 2021 02:56
CST Updated
02:56
Roche
Oncology Drug Research, Development, and Manufacturing
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
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November 14, 2021 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，As of 02:00 on November 14, 2021, the global cumulative confirmed casesMore than 250 million cases (253.43 million), with over 5.1 million deaths。
Recently, Roche announced that the European Commission (EC) has approved the antibody cocktail therapy Ronapreve (casirivimab and imdevimab, formerly known as: REGN-COV2):For the treatment of COVID-19 in adults and adolescents (aged ≥12 years, weight ≥40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe disease.；（2）For individuals aged ≥12 years and weighing ≥40 kg, for the prevention of COVID-19 (pre-exposure or post-exposure prophylaxis). This approval decision was made just one day after the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive review opinion, reflecting that both the EMA and EC have prioritized shortening the review time for safe, effective, and high-quality therapies during the COVID-19 pandemic.
Ronapreve, developed by Roche in collaboration with Regeneron, is an antibody cocktail therapy that can be used to treat non-hospitalized COVID-19 patients as well as prevent COVID-19. Clinical data shows,Ronapreve treatment reduced the risk of hospitalization for certain patients with mild to moderate COVID-19 and lowered the risk of developing symptomatic COVID-19 infection in individuals exposed to the virus.
Previously, Ronapreve has been approved in Japan, the UK, and Australia, and granted emergency or temporary use authorization in other regions (including the US, India, and Canada). Currently, through bilateral procurement agreements across multiple regions and economies (including middle-income countries), Ronapreve has been supplied to nearly 50 countries. Additionally, the World Health Organization (WHO) also recommends the use of Ronapreve for treating COVID-19 patients.
Currently, COVID-19 is still prevalent worldwide, partly due to various SARS-CoV-2 variants. In the past two months, new cases in Europe have remained above 180,000 per day. At present, the region reports the highest weekly case incidence rate globally, with cases on the rise as winter approaches. During this special period, Roche is committed to standing shoulder to shoulder with society, governments, healthcare providers, and all individuals dedicated to overcoming the common goal of the COVID-19 pandemic.
Levi Garraway, MD, Chief Medical Officer and Head of Global Product Development at Roche, stated: "We welcome the rapid approval by the European Commission, which adds to the growing recognition by regulatory authorities worldwide that Ronapreve is a crucial therapy for both the treatment and prevention of COVID-19. Despite increasing global vaccination rates, Europe is currently experiencing a fourth wave of the pandemic, and there remains a need for treatment options that address various levels of disease severity and the different variants of concern. We look forward to collaborating with other global regulatory bodies to continue addressing the challenges posed by COVID-19 together."
Ronapreve, developed by Roche in collaboration with Regeneron, is a cocktail therapy consisting of two monoclonal antibodies (casirivimab and imdevimab). These two antibodies target two independent, non-overlapping sites on the receptor-binding domain of the spike protein (S protein) of the novel coronavirus (SARS-CoV-2), working synergistically to reduce the risk of viral mutation escape and protect against variants with mutations in the S protein. Additionally, data from preclinical studies indicate that casirivimab and imdevimab retain neutralizing activity against key emerging variants.
This EU approval is based on data from two global Phase III clinical trials, including the treatment study REGN-COV 2067 conducted in high-risk non-hospitalized (outpatient) COVID-19 patients and the preventive study REGN-COV 2069 conducted in close contacts of COVID-19 patients.
REGN-COV 2067 is a randomized, double-blind, placebo-controlled Phase 3 trial in 4,567 patientsHigh-risk COVID-19 OutpatientsREGN-COV2 was evaluated in China. All patients assessed for efficacy had at least one risk factor for developing severe COVID-19, such as chronic lung disease (includingAsthma), obesity, cardiovascular disease, or age ≥50 years. The results showed,Compared with placebo, REGN-COV2 reduced hospitalization or death by 70% and shortened the duration of symptoms by 4 days.Significantly reduce viral load within 7 days of treatment.
REGN-COV 2069 is a randomized, double-blind, placebo-controlled, multi-part Phase 3 study evaluating Ronapreve.Prevention of Symptomatic COVID-19 Infection Among Household Contacts of COVID-19 PatientsEfficacy and safety. Results from the prevention cohort of close household contacts of COVID-19 patients showed:Among individuals who were not infected at the time of entering the trial,Ronapreve treatment reduced the risk of symptomatic infection by 81%.. FromRecent treatment cohort results for asymptomatic infected patients show: Ronapreve treatment reduced the risk of disease progression to symptomatic COVID-19 by 31%.. (Bioon.com)
