EMA issues advice on the use of Celltrion’s anti-COVID-19 monoclonal antibody treatment regdanvimab (CT-P59) for COVID-19 patients in the European Union

Celltrion Group announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for the company’s anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59). The CHMP recommends that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.

Under Article 5 (3) of Regulation 726/2004, the CHMP’s scientific opinion provides a harmonised EU- level opinion on the efficacy, quality and safety of antibodies. The scientific opinion can be considered by EU member states when making decisions on the possible use of monoclonal antibody therapies at a national level prior to a marketing authorisation.

The EMA has also initiated a rolling review of regdanvimab based on data from animal studies (non- clinical data) and clinical trials, in addition to data on the quality of the medicine. The EMA uses its rolling review process to accelerate the assessment of a promising medicine during a public health emergency and once finalised it will provide the basis of an EU marketing authorisation for the monoclonal antibody treatment.

“Today’s CHMP positive scientific opinion by the EMA takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against COVID-19 worldwide. Based on clinical data and CHMP’s positive scientific opinion, regdanvimab has been adopted and contracts for initial supplies have been made with distributors towards Nordic countries including Denmark, Norway, Sweden and Finland,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We believe the CHMP’s positive opinion will accelerate reviews and authorisations by national authorities who may take evidence-based decisions on the use of our therapy. We will also continue to work in close collaboration with the EMA to complete the rolling review and marketing authorisation process.”

Regarding mutations, the Korea Disease Control and Prevention Agency (KDCA) has independently confirmed that CT-P59 successfully neutralised the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants.

Global Principal Investigator Professor Adrian Streinu-Cercel, MD, PhD, Professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, commented, “CT-P59 has demonstrated its ability to shorten time to clinical recovery and reduce rate of progression to severe COVID-19. From the clinical trial, one of my patients with COVID-19 aged 85 and with an underlying condition, has recovered from the virus within 48 hours of being treated with CT-P59. The antibody treatment candidate would be most useful within 3-5 days of testing positive for the virus. This will greatly aid efforts to address the current burden on healthcare systems and resources.”