KUALA LUMPUR, Nov 15 (Bernama) -- Celltrion Group announced the European Commission (EC) has approved Regkirona (regdanvimab, CT-P59), one of the first monoclonal antibody treatments granted marketing authorisation from the European Medicines Agency (EMA).
According to a statement, the EC granted marketing authorisation for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
The decision from the EC follows a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Nov 11.
“Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” said Head of Medical and Marketing Division at Celltrion Healthcare, Dr HoUng Kim, Ph.D.
“As part of our global efforts to accelerate access, we have been communicating with the governments and contractors in 30 countries in Europe, Asia and LATAM. We will continue working with all key stakeholders to ensure COVID-19 patients around the world have access to safe and effective treatments.”
Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2, which works to block the path the virus uses to enter human cells.
The EC approval is based on the global Phase III clinical trial involving 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.
As of Nov 12, more than 22,587 people have been treated with regdanvimab at 129 hospitals in the Republic of Korea.
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies.
-- BERNAMA
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