EMA Recommends Approval of Two Monoclonal Antibody Therapies for COVID-19: Ronapreve and Regkirona
Regeneron
Biopharmaceutical Manufacturer
Roche
Oncology Drug Research, Development, and Manufacturing
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
Xinhua News Agency, The Hague, November 11th, by reporter Wang Xiangjiang — The European Medicines Agency recommended on the 11th that the European Commission approve two monoclonal antibody drugs for treating symptoms of coronavirus infection.
These two drugs are Ronapreve, jointly developed by Regeneron Pharmaceuticals, Inc. of the United States and F. Hoffmann-La Roche Ltd headquartered in Switzerland, and Regkirona, developed by South Korean pharmaceutical company Celltrion.
According to the recommendation of the European Medicines Agency's Committee for Human Medicinal Products, Ronapreve can be used to treat adult and pediatric patients aged 12 years and above, weighing 40 kg and above, who do not require supplemental oxygen but are at high risk of progressing to severe COVID-19. Ronapreve can also be used to prevent coronavirus infection in individuals aged 12 years and above, weighing 40 kg and above.
Moreover, the committee recommends authorizing Regkirona for the treatment of adult COVID-19 patients who do not require supplementary oxygen but are at high risk of progressing to severe disease.
The European Medicines Agency stated that these two drugs are the first monoclonal antibody drugs to receive a recommendation from the committee for authorization to treat symptoms of COVID-19 infection.
The committee's evaluation data shows that the use of these two drugs can significantly reduce the risk of hospitalization and death for COVID-19 patients facing the risk of worsening conditions. Studies also indicate that if someone in a household is infected with the coronavirus, Ronapreve can help other household members reduce the chance of infection.