Celltrion’s Regkirona (regdanvimab, CT-P59) was granted marketing authorization in the EU for the treatment of COVID-19 for adults that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19, while Roche’s Ronapreve has been endorsed by the Commission to treat non-hospitalized Covid-19 patients aged 12 years and above.
The EU authorization came after both drugs received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Ronapreve is a combination of monoclonal antibodies, casirivimab and imdevimab. Roche is developing this COVID-19 treatment jointly with its US partner, Regeneron.
Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2, which works to block the path the virus uses to enter human cells.
The Commission’s approval for Celltrion’s monoclonal antibody is based on the global Phase III clinical trial involving more than 1,315 people to evaluate the efficacy and safety of regdanvimab in 13 countries including the US, Spain, and Romania. Data, said the developer, showed regdanvimab significantly reduced the risk of COVID-19 related hospitalization or death by 72% for patients at high-risk of progressing to severe COVID-19.
In the case of Roche’s drug, the EU gave it the green light after reviewing the positive results obtained from two clinical trials: the REGN-COV 2067 and the REGN-COV 2069 studies.
In the REGN-COV 2067 trial, which was performed on non-hospitalized COVID-19 patients, Ronapreve reduced hospitalization or morality by 70%.
The REGN-COV 2069 prophylaxis study findings showed that the antibody combination reduced the risk of symptomatic infections by 81% in individuals exposed to COVID-19 but not infected when they enrolled.
When asked about the costs of its drug, Kevin Choi, head of marketing, Celltrion Healthcare, told us: “We plan to provide our treatment at a more affordable price than other monoclonal antibodies. In addition, the price will be negotiable based on the purchase volume by country.”
Currently in the EU region, each government covers 100% of the costs of using monoclonal antibody treatments, said the representative for the Korean company.
“In the future, we anticipate them to be covered partially by the co-pay system, depending on each country’s pricing and reimbursement (P&R) policy.”
High specificity and safety
The primary benefits of monoclonal antibodies, said the Celltrion representative, are their high specificity and safety.
“They are highly specific for a single target, so they rarely cause undesirable side effects.
“Although the treatment cost for monoclonal antibodies given intravenously (IV) could be considered higher than COVID-19 pills, these therapeutics have demonstrated a promising efficacy and safety profile," commented Choi.
Considering the mechanism of action of monoclonal antibodies - binding to the SARS-CoV-2 spike protein RBD which inhibits its interaction with the cellular receptor protein ACE2 – monoclonal antibodies could be considered as an effective and safe treatment for people with higher risk of serious symptoms of COVID-19, he continued.
“Treatment options will be critical in working to tackle the ongoing pandemic and monoclonal antibodies offer a key treatment option for those at high-risk of progressing to severe COVID-19, especially when considering possible drug-drug interactions (DDI) for other treatments.”
Engagement with regulators
Celltrion said it is having ongoing discussions with regulatory agencies and contractors in more than 30 countries in Europe, Asia and LATAM in relation to supply agreements to accelerate global access to regdanvimab.
Emergency use authorizations are currently in place in Indonesia and Brazil, and the monoclonal antibody treatment is fully approved in the Republic of Korea. Regdanvimab has not yet been approved by the US Food and Drug Administration (FDA), but the company said it is in discussion with the FDA to submit applications for an Emergency Use Authorization (EUA).
Roche chief medical officer and global product development head, Levi Garraway said: “We welcome this quick approval from the EU Commission, which adds to the growing number of health authorities that recognize 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.”
Ronapreve is approved in Japan and conditionally in the UK and Australia. It is also authorized for emergency use or temporary pandemic use in the US, Canada and India.