The EC approval follows EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation to authorise two Covid-19 drugs
Flags in front of the European Commission building in Brussels. (Credit: Sébastien Bertrand/Wikipedia.)
The European Commission (EC) has granted marketing authorisation for antibody treatments Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) to treat Covid-19.
The approval follows EMA’s Committee for Medicinal Products for Human Use (CHMP) positive opinion on Covid-19 drugs from Regeneron-Roche, and Celltrion.
Ronapreve, also called REGEN-COV in the US, is an antibody cocktail comprising casirivimab and imdevimab, jointly developed by Roche and Regeneron Pharmaceuticals.
The European regulator approved the drug for treating and preventing Covid-19 in adults and adolescents aged 12 years and above, weighing at least 40kg.
CHMP reviewed positive data from the REGN-COV 2067 study in non-hospitalised patients and the REGN-COV 2069 prophylaxis study in people exposed to SARS-CoV-2 virus.
Ronapreve has been approved in Japan and conditionally in the UK and Australia, and is authorised for emergency use in the US, India and Canada.
Roche intends to work with the EMA to further extend the marketing authorisation of the antibody therapy for the treatment of hospitalised Covid-19 patients.
Roche chief medical officer and global product development head Levi Garraway said: “We welcome this quick approval from the European Commission, which adds to the growing number of health authorities that recognise Ronapreve as an important therapy for the treatment and prevention of Covid-19.
“Although vaccinations are increasing globally, Europe is entering a fourth wave of rising cases and treatment options for the full range of disease severity and variants of concern are still needed.
“We look forward to working with additional global regulatory bodies as we continue to tackle Covid-19 together.”
Regkirona (regdanvimab), also called CT-P59 has been identified by Celltrion to treat Covid-19, based on its potential in neutralising the SARS-CoV-2 virus.
The EC approval indicated the drug for treating Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe Covid-19.
Regkirona is currently being reviewed in Indonesia and Brazil, and the monoclonal antibody treatment for emergency use authorisations, and is fully approved in the Republic of Korea.
It has not yet been approved in the US, but the company is in discussion with the US Food and Drug Administration to submit applications for an emergency use authorisation (EUA).
Celltrion is in talks with regulatory agencies in more than 30 countries in Europe, Asia and LATAM, regarding regdanvimab supply agreements.
Celltrion Healthcare medical and marketing division head HoUng Kim said: “Today’s achievement, coupled with CHMP positive opinion for regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges.
“Typically, the recommendations from the CHMP are passed on to the EC for rapid legally binding decisions within a month or two, however, given the unprecedented times, we have received the EC approval within a day.
“As part of our global efforts to accelerate access, we have been communicating with the governments and contractors in 30 countries in Europe, Asia and LATAM.
“We will continue working with all key stakeholders to ensure Covid-19 patients around the world have access to safe and effective treatments.”