GENEVA – Swiss pharmaceutical giant Roche today said Japan has become the first country to fully approve its Ronapreve antibody treatment for patients with mild to moderate Covid-19.
The approval is based on Phase 3 trials finding that the antibody cocktail dramatically reduces the likelihood that patients with mild to moderate symptoms will develop a serious illness causing hospitalisation or death.
Ronapreve, developed in cooperation with United States biotech firm Regeneron, was approved by Japan’s Health, Labour and Welfare Ministry, said Roche in a statement, confirming that it is 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,” said Roche chief medical officer and product development head Levi Garraway in a statement.
“Its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies.”
Roche said Phase 3 trials of Ronapreve showed that high-risk, non-hospitalised patients treated with the drug have a 70% reduction in subsequent hospitalisation and death.
It also shorted the period of symptomatic illness by four days, said the company, adding that Phase 1 trials showed the safety and tolerability of the drug among the Japanese population.
Outside Japan, the antibody combination has been authorised for emergency or temporary use in a number of countries and regions, including the European Union, the United States, India, Switzerland and Canada, it 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 are at high risk of developing severe disease. – AFP, July 20, 2021
