When will domestic COVID-19 Txs be officially approved?

Inquiries heat up MFDS’s online bulletin board

Voices rise for the approval of Ildong's 'Xocova' and Hyundai Bioscience's 'Xafty'

Voices calling for the approval of domestic COVID-19 treatments are rising.

 

Petitions and heated discussions are being made on the free bulletin board of the Ministry of Food and Drug Safety’s website for the marketing authorization and accelerated review of homegrown COVID-19 treatments.

 

The items that are receiving attention on the yay or nay of approvals are Ildong Pharmaceutical’s ‘Xocova (ensitrelvir)’ and Hyundai Bioscience’s ‘Xafty.’ Xocova was developed by Japan’s Shionogi Pharmaceutical.

 

Ildong Pharmaceutical conducted a domestic clinical trial for the drug.

 

The drug was unable to receive EUA in Korea last year, and the company applied for official marketing authorization for the drug in January this year.

 

However, 8 months have passed and the drug has not even been designated as a subject for expedited review until now.

 

On this, an MFDS official said, "It is difficult to disclose specifics on why a certain drug’s EUA review is being delayed.

 

In some cases, the pharmaceutical company is unable to make follow-up measures after the MFDS gives feedback like insufficient supplementary data after primary review.

 

The reason may differ by individual drug.” In the case of Xafty, a new drug candidate for COVID-19, Hyundai Bioscience submitted the results of its Phase II trial on Xafty to the Korea Disease Control and Prevention Agency in April to request emergency use approval.

 

According to Hyundai Bioscience, in a Phase II trial conducted on 300 patients, Xafty reduced the time to improvement of COVID-19 symptoms by 4 days compared with the placebo.

 

In particular, the company stressed that niclosamide, the main active ingredient of Xafty, has a verified profile as it has been used as an insect repellent for 60 years around the world.

 

Xocova applied for marketing authorization in January and and Xafty for EUA in April.

 

With their results still unknown, voices urging for results have been rising through public petitions and MFDS’s online bulletin board.

 

One person said, “It has been 6 months since Xocova applied for approval, and 3 months since the start of the EUA review for Xafty has started.

 

Why hasn’t the government decided upon their approval or non-approval still?

 

We’re talking about the same authorities that approved Paxlovid in only 7 days.” Another person wrote, "3 months have passed since the drug’s Phase II trial was completed, and the drug has not been granted the EUA still.

 

This is contrary to the purpose of granting EUAs.” Another added, "It is ironic that we seek to become a pharmaceutical powerhouse with pharmaceutical sovereignty in this state.

 

What is the reason for the delay in approval?”