JAPAN|
Roche, a Swiss pharmaceutical giant, announced Tuesday that Japan was the first country to approve Ronapreve’s anti-COVID-19 treatment.
Phase 3 trials showed that the antibody cocktail significantly reduced the risk that mild and moderate COVID-19 patients would become seriously ill, resulting in hospitalizations or even death.
Roche stated that Ronapreve was developed in collaboration with the US biotech company Regeneron. It was approved by Japan’s Ministry of Health, Labor and Welfare.Roche chief medical officer Levi Garraway, chief of product development, stated that Ronapreve had been shown to increase survival rates in high-risk Covid-19 patients.He said that the ability of the drug to resist emerging variants (including the Delta variant) has been shown in preclinical research.
Roche said the phase 3 trials of Ronapreve had shown that high-risk non-hospitalized patients treated with the drug had a 70 percent reduction in subsequent hospitalization and death.It also shorted the period of symptomatic illness by four days, Roche said, adding that the phase 1 trials had showed the safety and tolerability of the drug among the Japanese population.Outside Japan, the antibody combination has been authorized for emergency or temporary pandemic use in a number of countries and regions, including the European Union, United States, India, Switzerland and Canada, Roche said.The blend is currently undergoing a rolling review by the European Medicines Agency, which has granted its use as a treatment option for COVID-19 patients who do not require oxygen, but who are at high risk of developing severe disease. -Agence France-Presse