Japan approves Shionogi’s Covid antiviral under new emergency approval pathway

Japanese regulators on Tuesday signed off on Shionogi’s domestic Covid-19 antiviral drug, known as Xocova (ensiterelvir), making it the first approval under Japan’s emergency agency approval system.

The emergency approval, which has been with regulators since last February, is based on a safety profile involving more than 2,000 patients who took the pill and clinical symptom effectiveness for five typical symptoms associated with Omicron (the main point). and antiviral efficacy (a key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

New data from September showed that when given daily for five days, the pill significantly reduced symptoms such as stuffy or runny nose, sore throat, cough, heat or fever, and low energy or fatigue within 72 hours. it’s beginning, the company announced. A total of 1821 mostly vaccinated patients from Japan, South Korea, and Vietnam were included in this study.

The average time for a patient to experience relief from five symptoms of COVID-19 was significantly shorter in the group treated with low-dose ensiterelvir (acceptable dose) compared to the placebo group: 167.9 hours compared to 192.2 hours. According to the company, no significant side effects have been observed.

At the same time, the study also met its secondary endpoint of a reduction in viral RNA on day after the third dose.
Shionogi says it is seeking both standard approval and approval in other countries to provide access to low- and middle-income countries, in addition to working with the drug’s patent.

An antiviral drug developed in a joint research collaboration between Hokkaido University and Shionogi targets an enzyme in the SARS-CoV-2 virus called 3CL protease, which is necessary for virus replication.

In March, the Japanese government agreed to buy one million medical courses.
Meanwhile, Shionogi’s Japanese compatriot Fujifilm announced in October that it had begun development of its antiviral Avigan, or favipriavir, to treat COVID-19. In a recent release, Fujifilm explained that it stopped enrollment in Avi’s Phase 3 COVID-19 trial in March due to “changes in circumstances,” which included improved vaccinations and the proliferation of Omicron variants.

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