Ildong Pharmaceutical’s oral Covid-19 treatment Xocova (pipeline name: S-217822) will have the first to get Japan’s emergency use authorization (EUA) to score EUA in Korea, an official drug regulator said.
As the EUA in Japan is making slow progress, it will be almost impossible to obtain EUA in Korea before in Japan.
Ildong and Japan’s Shionogi Pharmaceutical collaborate to develop the Covid-19 pill, and Ildong conducts a local trial of Xocova.
In February, Shionogi applied for conditional approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Under the revised Pharmaceuticals and Medical Devices Act, Xocova became Japan's first drug to seek EUA.
However, on July 20, Japan’s Ministry of Health, Labor and Welfare (MHLW) decided to continue the review of Xocova, instead of granting EUA. The ministry said it would review the results of the ongoing phase 3 study and make the final decision.
Then, Ildong said in media interviews that it could first apply for EUA of Xocova in Korea.
The local EUA allows a supply of pharmaceutical or medical products unauthorized in Korea during public health crises such as a pandemic. After the Korea Disease Control and Prevention Agency (KDCA) requests EUA, the MFDS reviews it.
Korea Biomedical Review has learned that, under the local rules, drugs that have yet to obtain approval in other countries are not subject to EUA in Korea.
“Drugs subject to EUA are limited to those that have been approved in a foreign country recognized by the Minister of Food and Drug Safety as carrying out drug safety management at a level equivalent to or higher than that of Korea,” an official at the MFDS said.
The official went on to say that, under the guidance on approval and management of emergency use of drugs to respond to a public health crisis, the MFDS checks the move of member nations of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and regulatory bodies of the WHO-Listed Authority (WLA) including Japan.
The comments of the MFDS official indicate that Xocova, without Japan’s EUA, is unlikely to be eligible for EUA review in Korea.
Without the quarantine authorities’ decision to introduce Xocova in Korea, Ildong cannot apply for EUA.
Under the law, a drug company can apply for EUA when recognized by the Minister of Food and Drug Safety or upon the request of an administrative agency’s head, such as the commissioner of the KDCA.
A drugmaker cannot apply for EUA directly to the regulator.
To advance the local release of Xocova, Ildong will have to seek an official marketing approval process, just like general pharmaceutical products.
Ildong has not applied for a preliminary review to obtain a Xocova permit in Korea.
“We have not received any request from a related government agency to grant EUA for Xocova, and the pharmaceutical company has not applied for a preliminary review for Xocova,” the MFDS official said.