Celltrion's Regkirona receives conditional approval from Peru
Regkirona, Korea’s first Covid-19 treatment, won conditional use approval from regulators in Peru, Celltrion said Monday.
This came about a week after the company gained formal marketing approval for the treatment from the European Commission.
Celltrion said Regkirona will play a key role in treating patients in Peru, which has been suffering from a growing number of infections recently. The number of Covid-19 cases in Peru totaled 2.2 million as of Nov. 22, with about 201,000 related deaths. The daily Covid-19 cases is about 1,700, with 30 deaths.
The Korean Ministry of Food and Drug Safety approved Regkirona in September. A total of 23,781 patients at 130 hospitals in Korea received the treatment as of Nov. 18, according to the Korea Disease Control and Prevention Agency.
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.
“Celltrion was able to win the conditional approval from Peru’s health authorities based on Regkirona’s proved efficacy and safety revealed in the global Phase 3 clinicals,” said a spokesperson for Celltrion.
Based on Phase 3 trial results, Regkirona slows the progression rate of the disease by 70 percent, and by 72 percent for high-risk patients over 50 or those with underlying conditions.
BY SARAH CHEA [email@example.com]