The scientific opinion from the EMA’s human medicines committee (CHMP) - as per Under Article 5 (3) of Regulation 726/2004 - 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 authorization.
Regdanvimab is a monoclonal antibody, a type of protein that has been designed to attach to a specific structure called an antigen.
A rolling review of regdanvimab (CT-P59) has been initiated by the EMA in parallel to ongoing trials, to accelerate time to potential marketing authorization, said the Korean company.
In a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies before a formal application is submitted. Once the CHMP decides that sufficient data are available, the formal application can be submitted by the company. By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the medicine or vaccine can be authorized.
Earlier this month the EMA also started that fast track process for two monoclonal antibodies being developed by Eli Lilly to be used in combination for the treatment of COVID-19.
Efficacy against COVID-19 variants
Celltrion also outlined how CT-P59 has demonstrated neutralizing capability against key emerging mutations. It said the Korea Disease Control and Prevention Agency (KDCA) independently confirmed that CT-P59 successfully neutralized 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).
A cocktail therapy of CT-P59 with another monoclonal antibody candidate also demonstrated neutralizing capability against the UK (B.1.1.7) and South African (B.1.351) variants, added the developer.
Distribution deals
Moreover, the company has secured initial sales agreements for the monoclonal antibody with Nordic countries.
Based on clinical data and CHMP’s positive scientific opinion, contracts for initial supplies have been made with distributors towards Nordic countries including Denmark, Norway, Sweden and Finland, confirmed Dr HoUng Kim, head of the medical and marketing division at Celltrion Healthcare. “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.”
Trial data
Celltrion said that in testing, using in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I clinical trial of CT-P59 demonstrated a promising safety, tolerability, antiviral effect, and efficacy profile in patients with mild symptoms of COVID-19, it added.
Global principal investigator, Dr Adrian Streinu-Cercel, 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.”
