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Celltrion COVID-19 drug Regkirona (regdanvimab) was approved by EU
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Celltrion COVID-19 drug Regkirona (regdanvimab) was approved by EU. Celltrion monoclonal antibody drug Regkirona (regdanvimab) was approved by EU to treat high-risk COVID-19 patients!
Regkirona is used to treat adult patients who do not require supplemental oxygen and are at high risk of developing severe COVID-19 disease.
According to Baidu’s “New Coronavirus Pneumonia Epidemic Real-time Big Data Report”, as of 01:00 on November 17, 2021, more than 250 million cases (254 million) have been diagnosed globally . There were more than 5.12 million deaths.
Recently, the Korean biopharmaceutical company Celltrion Group announced that the European Commission (EC) has approved Regkirona (regdanvimab, CT-P59) for the treatment of COVID-19 adult patients who do not require supplemental oxygen and have an increased risk of developing serious diseases .
Currently, Regkirona has not been approved by the US FDA, but Celltrion is discussing with the FDA to submit an emergency use authorization (EUA) application.
Regkirona is one of the first monoclonal antibody drugs granted marketing authorization by the European Union .
In the same week, the European Union approved the Roche/Regeneron antibody cocktail therapy Ronapreve (casirivimab and imdevimab, formerly known as REGN-COV2) :
(1) For the treatment of COVID-19 that does not require oxygen supplementation and has an increased risk of developing a serious disease Adults and adolescents (age ≥ 12 years old, weight ≥ 40 kg) patients;
(2) For people ≥ 12 years old and weight ≥ 40 kg to prevent COVID-19 (pre-exposure or post-exposure prevention).
Regkirona and Ronapreve’s approval decision was made immediately after the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive review opinion on November 11, reflecting that EMA and EC will Shortening the review time for safe, effective, and high-quality therapies is a priority.
Under normal circumstances, if the CHMP issues a positive review opinion on the drug, the EC will usually make a review decision within 1-2 months.
A monoclonal antibody is a protein designed to attach to a specific target. In this case, it is the spike protein of the new coronavirus (SARS-CoV-2). Its role is to block the virus’s way into human cells. .
The EU approved Regkirona, based on data from a global phase 3 clinical trial . The trial involved 1,315 people in 13 countries including the United States, Spain, and Romania, and evaluated the efficacy and safety of Regkirona.
Data show that for patients who are at high risk of developing severe COVID-19, Regkirona treatment significantly reduces the risk of COVID-19-related hospitalization or death by 72% .
(source:internet, reference only)