GENEVA: Swiss pharmaceutical giant Roche said on Tuesday (Jul 20) that Japan had become the first country to fully approve its Ronapreve antibody treatment for patients with mild to moderate COVID-19.
The approval was based on phase 3 trials finding that the antibody cocktail dramatically reduced the likelihood that mild or moderate COVID-19 patients would develop into serious illness causing hospitalisation or death.
Roche said the phase 3 trials of Ronapreve had shown that high-risk non-hospitalised patients treated with the drug had a 70 percent reduction in subsequent hospitalisation 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 authorised 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.
Ronapreve, developed in cooperation with US biotech firm Regeneron, was approved by Japan's ministry of health, labour and welfare, Roche said in a statement, confirming it was the "first country" to do so.
"Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death," Roche chief medical officer and product development chief Levi Garraway said in a statement.
"Its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies," he said.
Roche Holding AG on Tuesday said that Japan has approved ronapreve for the treatment of patients with mild to moderate Covid-19.
The Swiss pharmaceutical company ROG, -0.67% said the approval is based on results from the global Phase 3 REGN-COV 2067 study, which found the antibody combination of casirivimab and imdevimab reduced hospitalization or death by 70% in high-risk, nonhospitalized patients.
“Ronapreve has been shown to improve survival in high-risk, non-hospitalized Covid-19 patients by reducing the risk of hospitalization and death,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
“In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies,” Mr. Garraway said.
Outside Japan, the antibody combination has been authorized for emergency use or temporary pandemic use in regions including in the European Union, the U.S., India, Switzerland and Canada.
It is currently undergoing rolling review by the European Medicines Agency.
Ronapreve is being jointly developed by Roche and Regeneron Pharmaceuticals Inc.
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