[팍스넷뉴스 민승기 기자] Ildong Pharmaceutical and Shionogi Pharmaceutical decided to “continue to review” Zocova, an oral COVID-19 treatment jointly developed, and postponed the decision to approve emergency use.
On the 20th, the Ministry of Health, Labor and Welfare of Japan decided to withhold approval of Zokova, which applied for emergency use authorization in Japan. The deliberation that day, which started at 18:00, was jointly conducted by a professional subcommittee composed of experts and a pharmacist subcommittee including lawyers.
The decision to hold the approval was made because it was believed that it was difficult to judge the validity of the submitted clinical data alone. At the previous specialized subcommittee, a decision was made to withhold approval, saying, ‘We need to discuss it more carefully’. This is because the overall improvement effect of the 12 symptoms of COVID-19 that Djokova had previously targeted was not clear.
Meanwhile, the Japanese Ministry of Health, Labor and Welfare’s next deliberation schedule has not been set. However, it is expected that the phase 3 clinical trial in Japan will be completed by the end of this year.
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