INCHEON, Korea–(BUSINESS WIRE)–Celltrion Group has submitted today a formal Application for Conditional Marketing Authorisation (CMA) to the Korean Ministry of Food and Drug Safety (MFDS). This submission is based on the data from global Phase II/III clinical trial of CT-P59, meeting objectives of clinical endpoints.
Celltrion has previously enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The top-line data of the global Phase II/III clinical trial of CT-P59 are to be presented in the first half of 2021.
“Today’s filing for Conditional Marketing Authorisation in Korea is a significant milestone in the fight against COVID-19,” said HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare. “We remain committed to closely working with the regulatory agencies worldwide including the U.S. FDA and the European Medicines Agency (EMA) to ensure that patients around the world have access to safe and effective treatment against COVID-19 as early as possible.”
Celltrion plans to initiate a global Phase III clinical trial, a pivotal part of the study in more than 10 countries to obtain more comprehensive safety and efficacy results of CT-P59. The company plans to submit Emergency Use Authorisation (EUA) to the U.S. FDA and Conditional Marketing Authorisation (CMA) to the European Medicines Agency (EMA) for CT-P59 in the coming months.
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Notes to Editors:
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.
Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.
The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.
Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1.
About CT-P59 (Regdanvimab)
CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.3 Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.3
FORWARD LOOKING STATEMENT
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1 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: December 2020
2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: December 2020
3 Celltrion. Data on file