Celltrion seeks marketing registration for Regkirona in Europe
The target is patients 18 or over who don’t require supplemental oxygen supply and are highly likely to become seriously ill, according to Celltrion.
The application comes seven months after the EMA started a “rolling review” of Korea’s first homegrown treatment in February. The EMA requested Celltrion submit additional documents for formal authorization based on the analysis that data about Regkirona are enough to undergo the formal review.
Celltrion believes “it is highly likely that the EMA will grant the official product approval early” as the agency has sufficiently conducted the verification process for various data through the rolling review.
In late September, Celltrion received use approval in Korea. A total of 16,862 patients at 114 hospitals across the country were injected with the treatment as of Sept. 30, according to data provided by Korea Disease Control and Prevention Agency.
“Celltrion is speeding up the approval process for Regkirona globally,” said a spokesperson for Celltrion. “We will endeavor to supply Regkirona quickly so that many high-risk patients can use it at early stages.”
According to the results of Regkirona’s Phase 3 trials, which were conducted on 1,315 patients with light and moderate symptoms, Regkirona reduced the progression rate by 70 percent compared to the placebo group. For high-risk patients over 50 or those with underlying diseases, the progression rate dropped by 72 percent.
Animal testing of the Regkirona Covid-19 treatment has also produced meaningful results confirming its effectiveness against the highly contagious Delta variant.
In late June, the European Commission selected Regkirona as a promising treatment for Covid-19.
BY SARAH CHEA [firstname.lastname@example.org]