Celltrion said that the Peruvian Drug Administration has granted conditional approval for Regkirona (ingredient: regdanvimab).

The Peruvian Drug Administration is an organization that performs a function similar to that of the Ministry of Food and Drug Safety (MFDS), and all medicines distributed in Peru must obtain an item approval from the drug administration.

According to Worldometer, a real-time statistics site for Covid-19, as of Nov. 22, the cumulative number of Covid-19 cases in Peru surpassed 2.2 million, and the cumulative death toll exceeded 200,000.

Celltrion stressed that while Peru has been confirming about 1,700 Covid-19 cases and 30 deaths daily, there is a high level of awareness about the possible spread of the Covid-19 virus as the country had witnessed daily cases and deaths exceeding 10,000 and 300 at the beginning of this year.

“Based on the safety and efficacy proven through large-scale global clinical data of Regkirona, the company has obtained a conditional use authorization from the Peruvian health authorities,” a company official said. “We will do our best to contribute to the prevention of the rapid spread of Covid-19 as many countries are adopting a ‘living with Covid’ scheme.”

Celltrion confirmed the safety and efficacy of Regkirona with the results of a 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 U.S., Spain, and Romania.

In the high-risk group treated with Regkirona, the incidence of severe cases decreased by 72 percent compared to the placebo group. The clinical symptom improvement time was also shortened by more than 4.7 days.

Regkirona obtained emergency use approval from Indonesian and Brazilian drug regulators in July and August based on such good results.

Celltrion also received product approval for the treatment from the Ministry of Food and Drug Safety and the European Medicines Agency in September and November, respectively.