Celltrion Receives a Positive Opinion from CHMP for Regdanvimab

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Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

Celltrion Group has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

According to a March 27, 2021 press release, the CHMP’s opinion recommends that regdanvimab can be considered as a treatment option for patients at high risk of severe COVID-19, if the medicine is reasonably likely to provide a clinical benefit and a low likelihood of harm. A rolling review of regdanivimab is already underway by EMA based on data from animal studies and clinical trials, in addition to data on the quality of the medicine.

“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 HoUng Kim, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “We believe the CHMP’s positive opinion will accelerate reviews and authorizations 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 authorization process.”


Global Principal Investigator Professor Adrian Streinu-Cercel, professor of Infectious Diseases at the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, added in the press release, “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.”

Source: Celltrion