Regkirona, the only COVID-19 antibody medication licensed for usage in South Korea, is no longer being used after it was discovered to be ineffective against the omicron form. Celltrion is the manufacturer of the medicine. Omicron is currently responsible for virtually all new infections in this area.
As previously reported in the media, the Korea Disease Control and Prevention Agency informed reporters on Wednesday afternoon that it has discontinued selling Regkirona as of February 18. According to the agency, the remaining stock of Regkirona will only be utilized for individuals who are determined to have variations other than omicron in their genetic makeup.
The FDA cited an in vitro research that found Regkirona was "considered to be unlikely to be efficacious against omicron" as a justification for restricting the drug's usage.
Because of the most recent results, a representative from the Korean Ministry of Food and Drug Safety has stated to The Korea Herald that the terms of approval for Regkiron have been changed. In the meanwhile, the following disclaimer has been added: Regkirona's neutralizing ability against omicron has been severely reduced. In instances when it is regarded to be beneficial, on the other hand, it can be administered," he stated.
According to the most recent product information for Regkirona available on the ministry's website, an in vitro investigation revealed that the medicine retained activity against COVID-19 variants of the alpha, zeta, eta, and iota subtypes. On the other hand, its action against the beta, gamma, delta, kappa, epsilon, and omicron gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gamma gam
In the absence of Regkirona, additional COVID-19 medications now available in Korea include Paxlovid, an oral antiviral therapy from Pfizer, and Remdesivir, an intravenous treatment from Gilead Sciences. However, they are not available to all patients who qualify for them.
According to the guidelines of the Centers for Disease Control and Prevention, Paxlovid is recommended to people in their 40s and above who have specific health issues. Remdesivir can be administered to clinically susceptible patients as young as 12 years old who are experiencing mild to moderate symptomatology.
Despite the fact that Regkirona's neutralizing capacity against omicron has been decreased, a Celltrion representative told The Korea Herald that the company would continue to work on developing a follow-up treatment that is effective against a wide range of variations of the virus.
According to the Korea Drug Control Agency's announcement on Thursday, the country intends to introduce alternatives such as GlaxoSmithKline's sotrovimab and AstraZeneca's Evusheld. According to the FDA, GSK's request for an emergency authorization was now being reviewed by the Drug Administration.
According to past evaluations by specialists, the decision to remove Regkirona from the front lines had been anticipated for quite some time.
Following the publication of a paper in the scientific journal Nature, Dr. Oh Myoung-don, the director of the National Medical Centers' clinical committee for emerging infectious illnesses, stated that omicron "incapacitates" numerous current antibody medicines, including Regkriona.
To date, all antibody medicines, with the exception of sotrovimab, have been withdrawn from the market as a result of the rise of the new variety in prevalence.
The US Food and Drug Administration updated its emergency use authorizations for COVID-19 antibody therapies from Regeneron and Eli Lilly a month ago to restrict their usage since they are unlikely to be effective against the omicron virus.
Dr. Kim Dong-wan, critical care and respiratory disease specialist at the city-run Busan Medical Center, told The Korea Herald in a phone interview on Jan. 7 that Regkirona, which was developed to protect against the original Wuhan virus, "wasn't working very well with delta patients." Regkirona is a vaccine that was developed to protect against the original Wuhan virus.
"Even with alpha, Regkirona maintained his effectiveness. "However, when delta took control, it was necessary to take it in conjunction with corticosteroids such as dexamethasone," he explained.
