KUALA LUMPUR, Nov 15 -- Celltrion Group has announced 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).
regdanvimab (CT-P59) is 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, according to a statement.
“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 Head of Medical and Marketing Division at Celltrion Healthcare, Dr HoUng Kim, Ph.D.
“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.”
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 US, Spain, and Romania.
Data showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72 per cent for patients at high-risk of progressing to severe COVID-19.
Rolling review of regdanvimab had been initiated by the EMA in 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.
More details at https://www.celltrionhealthcare.com/en-us.
-- BERNAMA
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