Celltrion announced on the 22nd that it has obtained a conditional use license from the Peruvian Drug Administration (Dirección Nacional de Medicamentos, DIGEMID) on the 16th local time for ‘Rekkorna (ingredient name: Regdanvimab)’, a treatment for COVID-19 antibody developed by Celltrion.
The Peruvian Drug Administration is an organization that performs a function similar to that of the domestic Ministry of Food and Drug Safety (MFDS). All medicines distributed in Peru must obtain an item approval (Registro Sanitario) from the Drug Administration.
According to Worldometer, a real-time statistics site for COVID-19, as of November 22, the cumulative number of COVID-19 cases in Peru surpassed 2.2 million, and the cumulative death toll exceeded 200,000. As of November, the daily number of confirmed cases is 1,700 and the death toll is at a stable level of 30, but earlier this year, the daily number of confirmed cases and 300 deaths exceeded 10,000, so there is a high level of awareness about the further spread of Corona 19. .
Rekkona confirmed the safety and effectiveness of the global phase 3 clinical trial conducted on 1,315 patients with mild and moderate COVID-19 in 13 countries around the world, including Korea, the United States, Spain, and Romania. In the high-risk group treated with Lekkorna, the incidence of severe cases was reduced by 72% compared to the placebo group, and the clinical symptom improvement time was also shortened by more than 4.7 days compared to the placebo group in the high-risk group, securing statistical significance.
In July and August, Rekkona obtained emergency use approval from the Indonesian Ministry of Food and Drug Safety (BPOM) and the Brazilian Food and Drug Administration (ANVISA), and in September and November, it was officially approved by the Ministry of Food and Drug Safety in Korea and Europe, respectively. permission has been obtained In addition, it is administered to 23,781 patients in 130 hospitals, as of November 18, counted by the Central Defense Countermeasures Headquarters, and is actively being used to treat COVID-19 patients in Korea.
A Celltrion official said, “Based on the safety and efficacy proven through large-scale global clinical data of Rekkorina, we have obtained a conditional use permit from the Peruvian health authorities. I will do my best to make it happen.”
