South Korean pharmaceutical company Celltrion said its Phase 3 clinical tests of COVID-19 treatment Rekirona proved the treatment’s safety and efficiency. Photo courtesy of Celltrion
SEOUL, June 16 (UPI) -- South Korean pharmaceutical company Celltrion announced that its antibody COVID-19 drug is safe and effective after global clinical trials.
In an online press conference Monday, the drugmaker said it conducted Phase 3 trials in 13 countries, including South Korea, Spain and Romania, from January to April.
Celltrion said its Rekirona treatment, South Korea's first locally made COVID-19 treatment, reduced the recovery period by 4.9 days on average, slowing severe symptoms of the virus in more than 70 percent of the 1,315 patients who participated in the tests.
In the trials, 85.8 percent of participants were White. The number of patients displaying side effects was similar to that of the placebo group, according to the company.
"In Korea, Rekirona was administered after winning conditional approval, so we carried out tests in European countries for the most part. That's why the proportion of Asians is low," said Celltrion's senior director Kim Sung-hyun, who leads the medical science division.
"Basically, we think the clinical results didn't show any gaps between Westerners and Asians," he said.
The Korean government granted conditional approval to the antibody treatment in February. After achieving top-line trial results, Celltrion said it would seek full authorization at home and abroad.
About 4,000 Korean patients have been treated with the drug.
Celltrion is analyzing how Rekirona performed in treating coronavirus variants, the results of which will be disclosed next month.
"Currently, a few COVID-19 treatments made by big firms like Eli Lilly and GlaxoSmithKline have won approval in the United States. But none of them received official approval in Europe," HMC Investment & Securities analyst Eom Min-yong told UPI News Korea.
"In the case that Celltrion is granted approval in Europe, it will be able to compete with other players and acquire a substantial market share. That's why Celltrion is focusing on Europe for its Rekirona treatment," he said.
KB Investment & Securities analyst Hong Ka-hye echoed these observations.
"It is positive news that Celltrion confirmed the safety and efficiency of its treatment among many patients," Hong said. "Based on the trial test, it will now try to get official approval in Europe and the U.S."
After the announcement, Celltrion's share price went up 5.84 percent on the Seoul bourse Monday, while that of its Celltrion Pharm unit rocketed 12.82 percent.