The CHMP has issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59) for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
The CHMP positive opinion for regdanvimab marks the first time a monoclonal antibody treatment for COVID-19 has received a recommendation for marketing authorisation from the European Medicines Agency (EMA).
The positive CHMP opinion was supported by data from the global Phase III clinical trial in which Celltrion enrolled more than 1315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the US, Spain, and Romania. Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19.
Rolling review of regdanvimab had been initiated by the EMA on February this year and the announcement of the CHMP positive opinion for regdanvimab follows the submission of a marketing authorisation application (MAA) to the EMA seeking approval of regdanvimab in October 2021.
“The primary benefits of monoclonal antibodies are their high specificity and safety – they are highly specific for a single target, so these monoclonal antibodies rarely cause undesirable side effects,” said Oana Sandulescu, MD, PhD, Associate Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy in Romania. “An infusion of an hour of monoclonal antibodies like regdanvimab can ease COVID-19 symptoms and reduce complications in recently diagnosed, non-hospitalised people at high risk, and thus plays an important role in preventing further spread of the virus.”