Celltrion has applied for conditional permission for’Rekirona’, an antibody treatment for novel coronavirus infection (Corona 19). yunhap news
Expectations for the country’s first new coronavirus infection (Corona 19) treatment are growing. Celltrion is scheduled to announce the results of phase 2 clinical trials of’Rekironaju’, a corona 19 antibody treatment, at the conference of the Korean Pharmacopoeia at 6 pm today. On this day, Joong-sil Eom, a professor of infectious medicine at Gachon University Gil Hospital, will be presented.
Celltrion has already applied for conditional approval of Rekirona to the Ministry of Food and Drug Safety. With the completion of phase 2 clinical trials, it will acquire permission to use phase 3 conditionally. To this end, Celltrion evaluated the safety and effectiveness of Rekirona injection in 327 patients with mild to moderate Corona19 in phase 2 clinical trials.
Celltrion did not disclose detailed clinical data at the time of application for approval. As attention has been overly focused on the treatment for COVID-19, it has decided to keep the clinical data private until there is a separate instruction at the request of the Ministry of Food and Drug Safety.
However, it was pointed out that undisclosed clinical results would rather cause confusion. Following this point, Celltrion decided to disclose the results of clinical data at the conference that day.
Celltrion claims that Rekironaju has enough elements to be recognized for its excellent efficacy and safety as a treatment for Corona 19. Celltrion R&D Director Kwon Ki-seong said at the National Assembly discussion on the day before, “Compared with Lili and Regeneron antibody treatments, we have confirmed the same or better effect.”
Currently, Remdesivir of Gilead Sciences, a multinational pharmaceutical company, is the only drug approved in Korea. The industry predicts that the results of the approval from the Ministry of Food and Drug Safety will come out as early as the end of this month. When Rekirona State gets permission from the Ministry of Food and Drug Safety, it will become the first domestic Corona 19 treatment.
Reporter Jang Joo-young [email protected]