European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of Covid-19 drugs from Regeneron-Roche, and Celltrion.
Ronapreve (casirivimab/imdevimab) is jointly developed by Roche and Regeneron and Regkirona (regdanvimab) is developed by Celltrion to treat Covid-19.
Ronapreve, also called REGEN-COV in the US, is an artificial antibody cocktail designed to produce resistance against the SARS-CoV-2 virus.
In the preclinical studies, the antibody cocktail retained the neutralisation activity against emerging variants, and the data was published in Cell and Nature, said Roche.
CHMP indicated the drug for treating and preventing Covid-19 in adults and adolescents aged 12 years and above, weighing at least 40kg, who do not require supplemental oxygen and at elevated risk of disease progression.
The current recommendation is based on positive data from the REGN-COV 2067 treatment study and the REGN-COV 2069 prophylaxis study.
Ronapreve has been approved for use in Japan, conditionally in Australia and the UK, and is authorised for emergency use in the US, India and Canada.
Roche chief medical officer and global product development head Levi Garraway said: “Ronapreve has demonstrated efficacy in treating and preventing Covid-19 and against variants of concern.
“People with Covid-19 across Europe are already being treated with Ronapreve based on emergency authorisations that followed the CHMP’s scientific opinion earlier this year.”
Regkirona is a monoclonal antibody intended for the treatment of Covid-19. It was identified through screening of antibody candidates with potential in neutralising the SARS-CoV-2.
The Committee recommended the drug for treating adults with Covid-19 that do not require supplemental oxygen and are at high risk of disease progression.
The positive CHMP opinion was supported by data from the Phase 3 clinical trial that evaluated the efficacy and safety of Regkirona in more than 1,315 people.
In the study, the drug significantly reduced the risk of Covid-19 related hospitalisation or death by 72% for patients at high risk of progressing to severe Covid-19.
EMA started the rolling review of Regkirona in February this year, and the CHMP recommendation follows Celltrion’s marketing authorisation application (MAA), last month.
Celltrion Healthcare medical and marketing division head HoUng Kim said: “At Celltrion, we are proud to play our part in tackling the unprecedented global threat of Covid-19 and believe regdanvimab offers an important addition to the treatment arsenal.
“Currently, we are in discussions with regulatory agencies and companies from approximately 30 countries around the world, to supply our monoclonal antibody treatment for Covid-19 and those will be our top priorities in the coming months.”
According to EMA, Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for Covid-19.
