CelltrionHealthcare

Celltrion submits Marketing Authorisation Application to the European Medicines Agency for regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19

·         The European Medicines Agency (EMA) accepted application for marketing authorisation for regdanvimab (CT-P59) as sufficient evidence is available

·         Submission supported by previously announced data from the global Phase III clinical trial; EMA to assess the benefits and risks of regdanvimab (CT-P59) under a reduced timeline

·         Celltrion anticipates accelerating time to potential marketing authorisation following the positive scientific opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the EMA of regdanvimab (CT-P59)

October 05 2021, INCHEON, KOREA – Celltrion Group today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of regdanvimab (CT-P59), a monoclonal antibody treatment for COVID-19. The indication applies for the treatment of confirmed COVID-19 in adults (≥18) who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.

In March, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for regdanvimab (CT-P59) as it can be considered a treatment option for patients at high risk of progressing to severe COVID-19 and based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.[1] In addition, in June, the European Commission (EC) announced Celltrion’s regdanvimab to be part of the COVID-19 therapeutics portfolio for authorisation for the treatment of COVID-19 patients as part of its strategy for COVID-19 therapeutics.

“We are once again encouraged with the regulatory milestone that brings us close to providing an effective treatment of COVID-19,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “As we continue to face serious health challenges from COVID-19, we will closely liaise with the regulatory agency to fast track the decision granting the marketing authorisation of regdanvimab in all EU and EEA member States.”

Celltrion has successfully enrolled more than 1,315 people in its global Phase III clinical trial, which evaluated the efficacy and safety of regdanvimab (CT-P59) in 13 countries including the U.S., Spain, and Romania. Data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients. In addition, pre- clinical data for regdanvimab (CT-P59) demonstrated strong neutralising activity against the Delta variant (B.1.617.2, first identified in India) with results showing 100% survival rate with virus eradication from all animals treated with therapeutic dosage of CT-P59.

As of October 2021, more than 16,862 people have been treated with regdanvimab (CT-P59) in 114 hospitals in the Republic of Korea. 

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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.

About regdanvimab (CT-P59)

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. In vitro and in vivo pre- clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern including the Alpha variant (B.1.1.7, first identified in the UK). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and II clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19.[2] Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.

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