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• The approval marks the primary time a monoclonal antibody remedy for COVID-19 obtained full approval to deal with sufferers with COVID-19
• The approval contains an growth of sufferers that may be handled with regdanvimab (CT-P59) for COVID-19 and a lowered time interval for the remedy administration
• Celltrion continues discussions with international regulators to make regdanvimab (CT-P59) accessible to sufferers with COVID-19
Incheon, South Korea–(Antara/Enterprise Wire)- Celltrion Group introduced that the Korean Ministry of Meals and Drug Security (MFDS) authorized regdanvimab (CT-P59), a monoclonal antibody remedy for COVID-19 for the prolonged use in aged sufferers aged 50 years and over, or with at the least one underlying medical situation (the overweight, heart problems, persistent lung illness, diabetes, persistent kidney illness, persistent liver illness, and sufferers with immunosuppressive brokers) with delicate signs of COVID-19, and grownup sufferers with reasonable signs of COVID-19. This marks the primary time a monoclonal antibody remedy for COVID-19 has obtained a full approval to deal with sufferers with COVID-19 from the Korean MFDS.
In February, the Korean MFDS granted a Conditional Advertising Authorisation (CMA) for the emergency use of regdanvimab (CT-P59) and allowed the usage of CT-P59 in grownup sufferers aged 60 years and over, or with at the least one underlying medical situation (cardiovascular, persistent respiratory illness, diabetes, hypertension) with delicate signs of COVID-19, and grownup sufferers with reasonable signs of COVID-19.
The administration time for the advisable dosage of regdanvimab (CT-P59), a single intravenous (IV) infusion of 40 mg/kg, has been lowered from 90 minutes to 60 minutes.
Celltrion has efficiently enrolled greater than 1,315 individuals in its international Part III scientific trial, which evaluated the efficacy and security of regdanvimab (CT-P59) in 13 international locations together with the U.S., Spain, and Romania. Knowledge confirmed regdanvimab (CT-P59) considerably lowered the danger of COVID-19 associated hospitalisation or demise by 72% for sufferers at high- danger of progressing to extreme COVID-19 and 70% for all sufferers. As well as, pre- scientific knowledge for regdanvimab (CT-P59) demonstrated robust neutralising exercise in opposition to the Delta variant (B.1.617.2, first recognized in India) with outcomes exhibiting 100% survival charge with virus eradication from all animals handled with therapeutic dosage of CT-P59.
“Latest scientific knowledge have helped enhance healthcare professionals’ and public well being authorities’ understanding of the potential position of regdanvimab within the remedy of sufferers with mild-to-moderate signs of COVID-19,” mentioned Dr. HoUng Kim, Ph.D., Head of Medical and Advertising Division at Celltrion Healthcare. “Regdanvimab is the primary of its type for the remedy of COVID-19, so the efficacy and security profile needs to be assessed completely. Together with a steady and optimistic suggestions from professional scientists and clinicians, we’re inspired by the choice of regulatory company to substantiate this remedy is secure and efficient. Celltrion group stays in diligent communication with different regulatory authorities worldwide.”
As of September 2021, greater than 14,857 individuals have been handled with regdanvimab (CT-P59) in 107 hospitals within the Republic of Korea.
– ENDS -
Notes to Editors:
About Celltrion Healthcare
About regdanvimab (CT-P59)
CT-P59 was recognized as a possible remedy for COVID-19 by screening of antibody candidates and choosing people who confirmed the best efficiency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre- scientific research confirmed that CT-P59 strongly binds to SARS-CoV-2 RBD and considerably neutralise the wild kind and mutant variants of concern together with the Alpha variant (B.1.1.7, first recognized within the UK). In in vivo fashions, CT-P59 successfully lowered the viral load of SARS-CoV-2 and irritation in lung. Outcomes from the worldwide Part I and II scientific trials of CT-P59 demonstrated a promising security, tolerability, antiviral impact and efficacy profile in sufferers with mild- to- reasonable signs of COVID-19.1 Celltrion additionally has just lately commenced the event of a neutralising antibody cocktail with CT-P59 in opposition to new rising variants of SARS-CoV-2.
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References
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1 Celltrion Knowledge on file
Contacts
Holly Barber
+44 (0) 7759 301620
Donna Curran
+44 (0) 7984 550312
Supply: Celltrion Healthcare
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