Japan's Ministry of Health, Labor and Welfare approved Shionogi new crown oral drug EUA
On November 22, Japan's Ministry of Health, Labor and Welfare approved Shionogi new crown oral drug EUA.
Previously, on September 28, Shionogi announced that the Phase III portion of a Phase II/III clinical trial of the 3CL protein inhibitor Ensitrelvir Fumaric Acid (S-217622) in Asia met the primary endpoint.
The results showed that, for the first time, ensitrelvir was shown to significantly reduce the time to remission of the five typical symptoms of Omicron compared to placebo. At the same time, ensitrelvir also showed a significant reduction in viral RNA load on day 4 (after the third dose).
This is the second 3CL drug after Pfizer paxlovid. The difference is that paxlovid needs to be used in combination with ritonavir. Enstirelvir alone can be effective.
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