- EU marketing authorisation follows approvals in Japan, the United Kingdom and Australia
- Approval based on data demonstrating Ronapreve reduced risk of hospitalisation in certain patients with mild to moderate disease and reduced risk of symptomatic COVID-19 infections in people exposed to the virus
Roche moment blazoned that the European Commission has granted a marketing authorisation for Ronapreve ™ (casirivimab and imdevimab), for treating COVID-19 in grown-ups and adolescents (from 12 times of age and importing at least 40 kilograms) who don’t bear supplemental oxygen and who are at increased threat of their complaint getting severe, and for precluding COVID-19 in people aged 12 times and aged importing at least 40 kilograms (pre-orpost-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 precedence to dock review timelines for safe, effective and high- quality rectifiers during the COVID-19 public health exigency.
“ We drink this quick blessing from the European Commission, which adds to the growing number of health authorities that fete Ronapreve as an important remedy for the treatment and forestallment of COVID-19,” said Levi Garraway,M.D.,Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “ Although vaccinations are adding encyclopedically, Europe is entering a fourth surge of rising cases and treatment options for the full range of complaint inflexibility and variants of concern are still demanded. We look forward to working with fresh global nonsupervisory bodies as we continue to attack COVID-19 together.”
Moment’s decision from the European Commission is grounded on the EMA’s CHMP’s review of positive data from the REGN-COV 2067 treatment study innon-hospitalised cases and the REGN-COV 2069 prophylaxis study in people exposed to SARS-CoV-2 contagion. Roche will continue to work with the EMA to potentially extend the marketing authorisation of Ronapreve to treat hospitalised cases with COVID-19.
Outside of the European Union, Ronapreve has been approved for use in Japan and conditionally in the United Kingdom and Australia, and is authorised for exigency or temporary epidemic use in fresh homes, including the United States, India and Canada. Ronapreve, being concertedly developed by Roche and Regeneron, is presently available in nearly 50 countries via bilateral purchase agreements across numerous topographies and husbandry, including lower middle- income countries. In addition, the World Health Organization recommended the use of Ronapreve for the treatment of cases with COVID-19.
COVID-19 remains current across the world, incompletely due to the multiple SARS-CoV-2 variants in rotation. In the once two months, new cases in Europe have reached> per day constantly. Presently, the region reports the loftiest daily case prevalence rates worldwide and cases are on the rise as we enter the downtime season.1 In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working towards the common thing of prostrating the COVID-19 epidemic.
About Ronapreve ™ (casirivimab and imdevimab)
The efficacity and safety of Ronapreve ™ (casirivimab and imdevimab, known as REGEN-COV ® in the United States) have been studied across multiple phase III clinical trials innon-hospitalised and hospitalised COVID-19 cases, and in the preventative setting. In addition, data from preclinical studies showed that Ronapreve retained neutralisation exertion against crucial arising variants, as substantiated in publications in Cell and Nature.
The decision from the European Commission is grounded on data from multiple studies, including
the REGN-COV 2067 study, showing that Ronapreve reduced hospitalisation or death by 70 and symptom duration by four days.
the REGN-COV 2069 study, showing that the administration of Ronapreve reduced the threat of characteristic infections by 81 in those who weren’t infected when they entered the trial.
There have been no new safety signals linked for Ronapreve in these studies.
Ronapreve is being concertedly developed by Roche and Regeneron. It’s a combination of two monoclonal antibodies, casirivimab and imdevimab, and was designed to block infectivity of SARS-CoV-2, the contagion that causes COVID-19.
About Roche’s response to the COVID-19 epidemic
As a leading healthcare company, we’re doing all we can to support countries in their fight against COVID-19 and minimising its impact. We’ve developed a growing number of individual results that help to descry and diagnose the infection, as well as furnishing digital support to healthcare systems. We also continue to identify, develop and support implicit curatives which can play a part in treating the complaint.
The impact of COVID-19 goes beyond those who contract it. That’s why we’re working with healthcare providers, laboratories, authorities and organisations to help make sure cases continue to admit the tests, treatment and care they need during these grueling times. Structure on a longstanding tradition of hookups, we’re working together with governments and others to make healthcare stronger and further sustainable in the future.
Roche is a global colonist in medicinals and diagnostics concentrated on advancing wisdom to ameliorate people’s lives. The combined strengths of medicinals and diagnostics, as well as growing capabilities in the area of data- driven medical perceptivity help Roche deliver truly personalised healthcare. Roche is working with mates across the healthcare sector to give the stylish care for each person.
Roche is the world’s largest biotech company, with truly discerned drugs in oncology, immunology, contagious conditions, ophthalmology and conditions of the central nervous system. Roche is also the world leader in in vitro diagnostics and towel- grounded cancer diagnostics, and a frontrunner in diabetes operation. In recent times, the company has invested in genomic profiling and real- world data hookups and has come an assiduity- leading mate for medical perceptivity.