Ministry of drug safety approves use of Celltrion’s Covid-19 treatment
Celltrion’s Covid-19 treatment Regkirona was approved for use by the Ministry of Food and Drug Safety, the Korean bio company said Friday.
The green light comes seven months after the ministry gave the company conditional approval in February.
"After reviewing Regkirona's Phase 3 clinical trial results, we have decided to give it an official use approval with some changes," said a spokesperson from the Ministry of Food and Drug Safety.
The changes include an expansion of patients that can be injected with the treatment and a reduced time period for the administration of the treatment.
According to the ministry, Regkirona can be used for high-risk Covid-19 patients with non-severe symptoms and all patients with moderate and serious symptoms. In terms of people with non-severe symptoms, it was only administered to people who are aged 60 or older, but that has been changed to include people from the age of 51 and up.
The injection time has been reduced from 90 minutes to 60 minutes.
"The approval from the Ministry of Food and Drug Safety was decided based on many experts' judgement about the efficacy of Regkirona in treating the Covid-19 virus," said a spokesperson for Celltrion. "We will work our best to extend the usage of Celltrion in many medical sites in Korea as the number of Covid-19 patients has been surging recently."
"Also, we will endeavor to prove its safety against various variants."
A total of 14,857 patients from 107 hospitals across the country were injected with the treatment as of Sept. 17, according to data provided by Korea Disease Control and Prevention Agency.
In June, Celltrion shared top line results of Regkirona’s Phase 3 trials — the last round of clinical trials required for the drug. The most important data set in proving efficacy was the progression rate, which refers to the speed at which a patient's condition worsens.
Regkirona reduced the progression rate by 70 percent compared to the placebo group. For high-risk patients aged over 50 years or those with underlying diseases, the progression rate dropped slightly more, by 72 percent. Phase 3 clinical trials were conducted in 13 countries, including Korea, in January. A total of 1,315 patients with light and moderate symptoms took part. Classified into two groups, the volunteers were injected once with either Regkirona or the placebo drug in April.
Animal testing of the Regkirona Covid-19 treatment have also produced meaningful results confirming its effectiveness against the highly contagious Delta variant.
On Friday, Celltrion also said it will move quickly to obtain approvals from various overseas countries. Currently, Regkirona received an emergency use authorization from regulators in Brazil and Indonesia.
BY SARAH CHEA [firstname.lastname@example.org]