Celltrion’s regdanvimab is Korea’s first emergency-approved COVID-19 treatment.
All 156 state-designated COVID-19 medical institutes are eligible for free distribution of regdanvimab, Celltrion said, upon individual submission of supply request.
Patients who can receive the shot are confirmed COVID-19 patients who have yet to pass seven days from the first onset of symptoms, who do not require ventilators, who are 60 or older and with underlying illness such as chronic heart or respiratory disease, diabetes, high blood pressure or pneumonia.
The distribution will be a first-come-first-served basis. Celltrion’s subsidiary Celltrion Pharm will oversee the distribution in Korea.
Celltrion said that it currently has enough stock of regdanvimab to treat 100,000 people. The company plans to additionally manufacture the therapy for 1.5 million to 3 million people a year, depending on global demands.
Celltrion is seeking to apply for emergency approval of regdanvimab in Europe and the US. Regdanvimab in phase 2 clinical trial had shown 54 percent clinical improvement in mild and moderate COVID-19 cases.
Overseas, Celltrion will be up against US companies Eli Lilly and Regeneron.
Eli Lilly’s bamlanivimab and Regeneron’s casirivimab-imdevimab combination infusions are also monoclonal antibodies, who gained the US’ Food and Drug Administration’s emergency use approval in November 2020 for mild to moderate COVID-19 cases.
At the time of the FDA emergency approval, the therapies had no data to prove their efficacy for hospitalized patients requiring oxygen support, which had prompted the FDA to include that “monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.”
By Dec. 29, Regeneron had affirmed that an ongoing phase 3 test of its cocktail passed the futility analysis in hospitalized COVID-19 patients requiring low-flow oxygen. This meant that the drug proved enough efficacy to continue research in the hospitalized cohort. Regeneron’s cocktail was the treatment used on former US President Donald Trump when he had been diagnosed with COVID-19 in October 2020.
Eli Lilly is also continuing to strengthen the data of its treatment candidate. On Jan. 26, Eli Lilly reported that bamlanivimab, used together with etesevimab, reduced the risk of COVID-19 hospitalizations and death by 70 percent in a phase 3 trial.
Regeneron’s casirivimab-imdevimab and Eli Lilly’s bamlanivimab-etesevimab are both being reviewed by the European Medicines Agency for potential emergency use in Europe, for COVID-19 patients who do not require oxygen support but have risk of progressing to severe cases.
Eli Lilly is partnered with Korea’s Samsung Biologics for contract development and manufacturing of its COVID-19 antibody therapy.
By Lim Jeong-yeo (email@example.com)