Overcoming Emergency Use Approval Failure with Formal Product Authorization
Interest in Becoming the First Domestic Oral Treatment
Oral COVID-19 treatment 'Zokoba' jointly developed by Ildong Pharmaceutical and Japan's Shionogi [Image source=Reuters Yonhap News]
[Asia Economy Reporter Chunhee Lee] Ildong Pharmaceutical, whose emergency use authorization (EUA) for the oral COVID-19 treatment 'Jokoba' (development name S-217622, ingredient name Ensitrelvir Fumarate) was rejected, has taken a straightforward approach by applying for formal product approval.
On the 3rd, Ildong Pharmaceutical announced that it had applied for product approval of Jokoba tablets 125 mg for COVID-19 infection as the target disease to the Ministry of Food and Drug Safety in South Korea. A representative from Ildong Pharmaceutical explained, "We applied for product approval to facilitate rapid domestic introduction."
Jokoba is an oral antiviral drug taken once daily (three times on the first day) for five days. It selectively inhibits the viral protein-degrading enzyme 3CL-protease, which is necessary for the replication of the COVID-19 virus, thereby preventing viral proliferation. Ildong Pharmaceutical and Japan's Shionogi Pharmaceutical jointly developed the drug.
In a Phase 3 clinical trial involving 1,798 participants conducted in South Korea, Japan, Vietnam, and other countries, Jokoba showed an effect of shortening the time to resolution of five characteristic symptoms of the Omicron COVID-19 variant?fever, cough, sore throat, runny nose and nasal congestion, and fatigue?to 167.9 hours in the Jokoba group compared to 192.2 hours in the placebo group, reducing the duration by more than 24 hours.
Currently, Jokoba received EUA in Japan last month after three attempts, and related procedures are under review in the United States and Europe. Domestically, Ildong Pharmaceutical secured the Korean distribution rights from Ping An Shionogi, a joint venture between Shionogi, which holds the Asian rights for Jokoba, and China's Ping An Insurance. Ildong Pharmaceutical had planned to produce the first domestically made oral COVID-19 treatment by pursuing domestic production after obtaining approval, but as the COVID-19 pandemic situation eased somewhat, the domestic EUA was canceled.
Accordingly, Ildong Pharmaceutical appears to have taken the straightforward approach of applying for product approval. However, since only about four months have passed since the completion of Phase 3 clinical trials, related data may be insufficient, making the early market entry that Ildong Pharmaceutical hoped for difficult.
Therefore, Ildong Pharmaceutical is expected to adopt a strategy similar to previously approved COVID-19 vaccines and treatments, which, although not formal conditional approvals, received earlier authorization on the condition of submitting final clinical trial reports and related documents later. The company will likely apply for product approval first and then supplement the necessary parts afterward to obtain faster approval.
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