Celltrion's Regkirona COVID-19 antibody treatment approved in Peru
Celltrion’s antibody treatment for COVID-19 has been granted approval for emergency use in Peru. The South Korean pharmaceutical company announced on Monday, Nov. 22, that the Peruvian authorities approved its Regkirona treatment for emergency application on adult patients with COVID-19.
According to Yonhap News Agency, Peru authorized Celltrion’s antibody treatment for emergency use based on recent results of phase three clinical study of the drug. The study was for attaining more comprehensive results for Regkirona’s effectiveness and safety, and since the results were good, it was approved.
The antibody treatment is being administered to patients in the form of an intravenous injection. It was said to be directly injected for 60 minutes.
Peru is the latest country to issue approval on Celltrion’s drug for treating COVID-19. It has already won approval from other states, such as Brazil and Indonesia, for emergency application. In its home base, which is South Korea, Regkirona has already won the authorities’ drug safety conditional approval in February.
One of the best things about the new drug is that it can lower the risk of COVID-19’s progress to severe levels. What’s more, Celltrion previously stated that its antibody treatment could also reduce the recovery time of patients.
Celltrion’s Regkirona is also South Korea’s very first COVID-19 treatment and it secured approval from Peru just a week after receiving marketing approval from the European Commission. The monoclonal antibody treatment was given the go-ahead last week.
Today’s achievement, coupled with Committee for Medicinal Products for Human Use (CHMP) positive opinion for Regdanvimab, underscores our ongoing commitment to addressing the world’s greatest health challenges,” Celltrion Healthcare’s head of medical and marketing, Dr. HoUng Kim, Ph.D., said in a press release. “Typically, the recommendations from the CHMP are passed on to the EC for rapid legally binding decisions within a month or two, however, given the unprecedented times, we have received the EC approval within a day.”
Meanwhile, the medical and marketing chief added that they are currently in talks with contractors and governments in 30 countries more across Asia, Europe, and Latin America. Celltrion said it would continue to work to make sure that COVID-19 patients worldwide will have access to safe and effective treatment.