• The CHMP positive opinion marks the first time a monoclonal antibody treatment for COVID-19 has received a recommendation for marketing authorisation from the EMA
• The recommendation is based on data from the global Phase III clinical trial investigating regdanvimab as a treatment for multiple variants of COVID-19, including the Delta variant
• Regdanvimab is the first authorised COVID-19 treatment approved from the Korean Ministry of Food and Drug Safety (MFDS); More than 21,366 people treated with regdanvimab in 127 hospitals in the Republic of Korea
Incheon, Korea--(ANTARA/Business Wire)- Celltrion Group announced today that the European Medicine’s Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59), a monoclonal antibody treatment for adults with COVID-19 that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union.
“We have accumulated the safety and efficacy data of regdanvimab in the treatment of patients infected with COVID-19 and its associated variant strains, including the more virulent Delta variant,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “At Celltrion, we are proud to play our part in tackling the unprecedented global threat of COVID-19 and believe regdanvimab offers an important addition to the treatment arsenal. Using our stable supply system and commercial network, we will expedite required process and continue to work with stakeholders globally to ensure eligible patients can benefit from this treatment as quickly as possible. Currently, we are in discussions with regulatory agencies and companies from approximately 30 countries around the world, to supply our monoclonal antibody treatment for COVID-19 and those will be our top priorities in the coming months.”
The positive CHMP opinion was supported by data from the global Phase III clinical trial in which Celltrion enrolled more than 1,315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the U.S., 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.
“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.”
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.
As of November 2021, more than 21,366 people have been treated with regdanvimab in 127 hospitals in the Republic of Korea.
Notes to Editors:
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.
About regdanvimab (CT-P59)
CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre- clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern. In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and Phase II/ III clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild-to-moderate symptoms of COVID-19.1 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.
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