Regdanvimab

Celltrion’s Monoclonal Antibody Treatment regdanvimab, Approved by the European Commission for the Treatment of COVID-19

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星期一, 十一月 15, 2021
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Regdanvimab, Safety, South Korea, European Commission, Celltrion, Terminology, EMA, Food, Inflammation, European Medicines Agency, Severe acute respiratory syndrome coronavirus 2, EC, COVID-19, Viral load, Criticism of the Food and Drug Administration, Committee for Medicinal Products for Human Use, Forward-looking statement, Protein, Hospital, Marketing, RBD, Korea, Committee, Medicine, US, EUA, Death, CHMP, European Directive on Traditional Herbal Medicinal Products, Emergency Use Authorization, Royal commission, Lung, Patient, Risk, FDA, EU, Vaccine, Pharmaceutical industry, Audit, Celltrion Healthcare, regdanvimab (CT-P59), CELLTRION HEALTHCARE, REGDANVIMAB (CT-P59)

Celltrion Group announced today that 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).

Key Points: 
  • Celltrion Group announced today that 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).
  • 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.
  • Emergency use authorisations are currently in place in Indonesia and Brazil, and the monoclonal antibody treatment is fully approved in the Republic of Korea.

Celltrion Receives CHMP Positive Opinion for regdanvimab (CT-P59) as One of the First Monoclonal Antibodies Recommended as a Treatment for COVID-19 by the CHMP

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星期四, 十一月 11, 2021
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Regdanvimab, Safety, Associate, South Korea, European, MD, MAA, European Commission, Celltrion, Infection, European Union, Doctor of Philosophy, Terminology, EMA, Inflammation, Union, Severe acute respiratory syndrome coronavirus 2, EC, Carol Davila University of Medicine and Pharmacy, COVID-19, Viral load, Committee for Medicinal Products for Human Use, Forward-looking statement, Hospital, Marketing, RBD, Korea, Committee, Medicine, US, Death, European Directive on Traditional Herbal Medicinal Products, CHMP, Royal commission, Lung, Patient, Risk, EU, Vaccine, Pharmaceutical industry, Audit, Celltrion Healthcare, regdanvimab (CT-P59), CELLTRION HEALTHCARE, REGDANVIMAB (CT-P59)

The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union.

Key Points: 
  • The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union.
  • 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.
  • As of November 2021, more than 21,366 people have been treated with regdanvimab in 127 hospitals in the Republic of Korea.
  • Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries.