Celltrion’s Covid-19 antibody therapy Regkirona (ingredient: regdanvimab) received official authorization from the European Commission (EC) on Friday.
The formal approval came just a day after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended Regkirona for the authorized use on Thursday.
EC generally approves of new pharmaceuticals one to two months after CHMP recommends for use. Celltrion said it considered the EC's decision to expand treatment access for patients to respond to the increasing infections in Europe quickly.
Celltrion applied for official marketing approval in early October, seven months after EMA began rolling review on Regkirona at the end of February.
EC approved Regkirona medically indicated for a single administration of 60 minutes to Covid-19 patients above 18 at risk of developing severe symptoms but do not require supplemental oxygen therapy.
The Covid-19 therapy also won approval from the Indonesia National Agency of Drug and Food Control in July and the Brazilian Health Regulatory Agency in August.
At home, the Ministry of Food and Drug Safety authorized its use in September. According to the health authorities, Regkirona has been administered to 22,857 patients in 129 hospitals.
The company verified the safety and efficacy of its Covid-19 drug in the global phase 3 clinical trials conducted on 1,315 patients with mild and moderate symptoms in 13 countries, including Korea, the U.S., Spain, and Romania.
Regkirona lowered the probability of high-risk patients developing into severe cases by 72 percent compared to the placebo group in the study. It also showed statistically significant results by shortening the time necessary for improving patients’ conditions by more than 4.7 days in the high-risk group compared to the placebo group.
Celltrion said it is discussing plans with more than 30 countries for supplying Regkirona. As related inquiries began increasing after the EC approval, the company said it plans to communicate closely with local partners for smooth overseas supply.
“It is unusual for the EC to issue an official approval just one day after the EMA gives a recommendation for approval to Regkirona,” a Celltrion official said. “We welcome the EC's prompt decision and step up the global supply of Regkirona for patients in Europe to contribute to ending the fight against the Covid-19.”