The Ministry of Food and Drug Safety announced Friday that it authorized Celltrion's Covid-19 antibody therapy, Regkirona, on the condition of submitting a phase 3 clinical trial results in the future.
The ministry held a final review committee and approved the use of Regkirona for treating mild patients in high-risk groups and adult patients with moderate symptoms after confirming the safety and efficacy of the drug, the first Covid-19 treatment developed by a Korean company.
Ministry officials also inspected the manufacturing plant of Regkirona, and found no problems, it said.
According to Celltrion's clinical data, the rate of progressing to severe patients requiring hospitalization decreased by 54 percent in the Regkirona plus standard therapy group compared to the placebo group who only received the existing treatment. It also confirmed that 68 percent of moderate patients over 50 who had pneumonia did not fall into severe conditions after receiving Regkirona with other therapy.
Regkirona combo group recovered an average of 3.4 days faster than those under standard treatment, 5.1 days earlier than moderately ill patients accompanying pneumonia, and 6.4 days quicker than moderate patients over 50 who had pneumonia.
Celltrion said that its Regkirona combination therapy lowered virus titer significantly faster than the existing treatment.
Regkirona is Korea's first homegrown Covid-19 therapy to receive authorization and the third antibody treatment verified by overseas regulators.
The ministry has checked the safety and efficacy profile of Regkirona since Celltrion submitted an approval request on Dec. 29. Regulators have reviewed the submitted data and conducted a close investigation on the quality, manufacturing facility, and clinical trial site.
"The ministry will work with related institutions to allow the company to conduct thorough phase 3 clinical trials and continue monitoring adverse events after the approval so that Regkirona can be used to those in need," Minister of Food and Drug Safety Kim Gang-lip said.
A Celltrion official said, "Our year-long efforts for developing Regkirona have finally been paid off with the conditional approval."
The official said that the company expects to supply Regkirona to reduce the time required to treat Covid-19 and lower the number of patients developing severe conditions that can lead to death.
The company plans to release more details of clinical results, authorized countries, and domestic and international supply plans as soon as possible, he added.