INCHEON, South Korea – (AFTERNOON PRAYER) – Celltrion Group announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a forward-looking scientific opinion for the candidate of anti-COVID monoclonal antibody treatment -19 of the company, regdanvimab (CT-P59). The CHMP recommends that regdanvimab may be considered a treatment option for high-risk patients to progress to true COVID-19, based on a reasonable likelihood that the drug may provide clinical benefit, and likelihood low on damage.1
Under Article 5 (3) of Regulation 726/2004, the scientific opinion of CHMP provides a consistent view at EU level on the efficacy, quality and safety of antibodies. The scientific idea can be considered by EU member states when making decisions on the possible use of monoclonal antibody treatments at national level before obtaining marketing approval.
The EMA has also initiated an ongoing review of regdanvimab based on data from animal studies (non-clinical data) and clinical trials, as well as data on the quality of treatment. The EMA uses its ongoing review process to accelerate promising drug evaluation in times of public health crisis and once completed will provide the basis of EU marketing approval for monoclonal antibody treatment.
“Today’s advanced scientific idea of CHMP with the EMA takes us one step closer to providing safe and effective monoclonal protection treatment against COVID-19 worldwide. Based on clinical data and good scientific opinion of CHMP, regdanvimab was adopted and contracts for original supply were made by distributors to Scandinavian countries including Denmark, Norway, Sweden and Finland, ”said Dr HoUng Kim, Ph.D., Head of Medical and Marketing at Celltrion Healthcare. “We believe that the CHMP’s forward thinking will accelerate reviews and authorizations by national authorities that can make evidence-based decisions about the use of our medicine. We will continue to work closely with the EMA to complete the ongoing review and marketing approval process. ”
In terms of mutations, the Korea Disease Control and Prevention Agency (KDCA) has independently confirmed that CT-P59 succeeded the SARS-CoV-2 variants first identified in the UK (B.1.1.7). in addition to the six previously mentioned variable genomes. mutations of SARS-CoV-2 (variables S · L · V · G · GH · GR). They also reported that cocktail therapy of CT-P59 with another monoclonal antibody candidate showed a neutral ability against changes in the UK (B.1.1.7) and South Africa (B.1.351).
Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, Chief Global Analyst, said CT-P59 has shown its potential shorten time to clinical recovery and rate reduction. of progress to hard COVID-19. Since the clinical trial, one of my patients with COVID-19 at age 85 and with an underlying condition, has recovered the virus within 48 hours of being treated with CT-P59. The most effective antibody treatment candidate would be available within 3-5 days of testing for the virus. This will greatly assist efforts to address the current burden on healthcare systems and facilities. ”
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Notes to Editors:
About Celltrion Health Care
Celltrion Healthcare is committed to delivering innovative and affordable medicines to improve patient access to advanced treatments. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with US FDA cGMP and EU GMP guidelines. Celltrion Healthcare strives to offer high cost-effective solutions through an extensive global network spanning more than 110 different countries. For more information visit: https://www.celltrionhealthcare.com/en-us.
In CT-P59 (regdanvimab)
CT-P59 was identified as a potential treatment for COVID-19 by screening antibody candidates and selecting those that showed the highest potential for neutralization of the SARS-CoV-2 virus. In vitro and in vivo preclinical studies have shown that CT-P59 binds strongly to SARS-CoV-2 RBD and significantly neutralizes the wild-type and mutant viruses of the UK variant (B). .1.17). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in the lung. Results from a global Phase I clinical trial of CT-P59 showed a promising image of safety, tolerability, antiviral effect and efficacy in patients with mild symptoms of COVID-19.2 Celltrion has also recently begun developing a neutral antibody cocktail with CT-P59 against emerging new variants of SARS-CoV-2.
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References
1 EMA issues advice on the use of regdanvimab for the treatment of COVID-19 | European Medicines Agency (europa.eu). Last accessed 26 March 2021.
2 Celltrion data on file