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

Roche 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 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 a 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.

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 emergency or temporary pandemic use in additional territories, including the United States, India and Canada. Ronapreve, being jointly developed by Roche and Regeneron, is currently available in nearly 50 countries via bilateral purchase agreements across many geographies and economies, including lower middle-income countries. In addition, the World Health Organization recommended the use of Ronapreve for the treatment of patients with COVID-19.

COVID-19 remains prevalent across the world, partly due to the multiple SARS-CoV-2 variants in circulation. In the past two months, new cases in Europe have reached >180,000 per day consistently. Currently, the region reports the highest weekly case incidence rates worldwide and cases are on the rise as we enter the winter season.1 In these exceptional times, Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, the company has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.