The Ministry of Food and Drug Safety (MFDS) said Friday that it has officially approved Paxlovid, Pfizer's oral Covid-19 treatment.

Paxlovid had previously received emergency use approval (EUA) during the Covid-19 pandemic in December of 2021.

However, the drug ministry granted full approval this time around after reviewing the results of a phase 3 clinical trial conducted on adult patients.

"Paxlovid has been officially approved in Korea under the Pharmaceutical Affairs Act following a thorough review of the results of a phase 3 clinical trial in adult patients," the MFDS said. "In addition to the official approval, the EUA will remain in place to ensure the continued use of Paxlovid, which is currently provided free of charge by the government."

Paxlovid is a combination of two tablets -- nirmatrelvir, which blocks the 3CL protease to prevent the production of proteins needed for virus replication, thus inhibiting virus growth, and ritonavir, which inhibits the enzyme that breaks down nirmatrelvir, thus prolonging the duration of nirmatrelvir.

It is used in adult patients with mild to moderate disease to prevent the disease from becoming severe.

What about Korean-made oral Covid-19 treatments?

In contrast to Paxlovid, the MFDS has yet to approve either Hyundai Bioscience's Zefty or Ildong Pharmaceutical's Xocova.

Earlier in May, Hyundai Bioscience submitted clinical data for Zefty to the Korea Disease Control and Prevention Agency (KDCA) for EUA.

Zefty is an oral Covid-19 treatment based on the anthelmintic drug niclosamide.

Under the current regulations, an EUA must be requested by the head of the KDCA and approved by the head of the Ministry of Food and Drug Safety.

For this reason, companies cannot directly apply for an EUA to the KDCA, but indirectly request a review.

After reviewing the data submitted by Hyundai Bioscience, the KDCA said that a review opinion from the MFDS is required on the company's clinical data, and the MFDS has been reviewing it through the expedited review system.

If the safety and efficacy are confirmed in the expedited review, MFDS is expected to start the process of reviewing whether to apply for EUA.

Ildong Pharmaceutical also submitted a formal application for a new drug license for Xocova to the MFDS in January this year and is currently undergoing the expedited review process.

Xocova is an oral Covid-19 treatment co-developed by Ildong and its Japanese partner, Shionogi Pharmaceutical.

Considering that the expedited review usually takes 180 days, the results will likely be available within July.

The industry is optimistic that Zefty and Xocova will receive approval, as clinical data for both drugs are looking good.

However, given that Korea's Covid-19 situation has entered an endemic phase and the availability of licensed treatments, industry officials believe that it is unlikely that these drugs will generate significant sales.