Regkirona receives marketing approval from European Commission
Regkirona, Korea’s first Covid-19 treatment, won marketing approval from the European Commission, Celltrion said Monday.
It is the first domestically-developed Covid-19 treatment to receive the permission from European Commission.
The green light came on Nov. 12, just a day after Celltrion, the developer of the treatment, received an approval recommendation from Committee for Medicinal Products for Human Use (CHMP) under European Medicines Agency (EMA). Celltrion applied for the marketing authorization in early October.
Celltrion said it is very rare for the European Commission to give the permission so quickly as it normally takes about one to two months to approve a new drug after CHMP’s recommendation.
The target is patients 18 or over who don’t require supplemental oxygen supply and are highly likely to become seriously ill, according to Celltrion. Regkirona is administered intravenously over a 60-minute period.
Celltrion Healthcare, a marketing company 24.3 percent owned by Celltrion founder Seo Jung-jin, is currently in talks with around 30 European countries. The number of contract inquiries has been increasing since the news about approval, Celltrion said.
The Ministry of Food and Drug Safety approved Regkirona in September. A total of 22,587 patients at 129 hospitals in Korea received the treatment as of Nov. 12.
Brazil and Indonesia issued emergency use authorizations for Regkirona, while the company is currently waiting for similar authorizations from Canada, Malaysia, Saudi Arabia, India and Mexico.
“It is very exceptional that European Commission gave the approval in only a day after EMA granted the recommendation,” according to a statement from Celltrion. “We greatly welcome the decision, and will try our best to supply Regkirona in European market as soon as possible to contribute to end the Covid-19 pandemic.”
Regkirona reduces the progression rate of the disease by 70 percent, according to the results of Phase 3 clinical trials, which were conducted on a total of 1,315 patients with light and moderate symptoms from 13 countries. For high-risk patients over 50 years of age or those with underlying conditions, the progression rate dropped by 72 percent.
Participants also recovered more rapidly. While patients injected with the placebo took an average 13.3 days to recover, those treated with Regkirona recovered in 8.4 days, a 4.9-day difference. Among high-risk patients, the Regkirona-treated group recovered in 9.3 days, around 4.7 days faster than the placebo group’s 14 days.
Animal testing of Regkirona has produced meaningful results demonstrating its effectiveness against the highly contagious Delta variant.
Celltrion rose 9.13 percent to 233,000 won ($198) Monday, while Celltrion Healthcare rose 8.42 percent to 92,700 won, and Celltrion Pharm jumped 16.15 percent to 137,400 won.
BY SARAH CHEA [firstname.lastname@example.org]