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GSK's NDA For Bepirovirsen Accepted In Japan For Chronic Hepatitis B

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

GSK plc (GSK) on Thursday said Japan's Ministry of Health, Labour and Welfare has accepted a new drug application for bepirovirsen for the treatment of adults with chronic hepatitis B (CHB).

The submission is supported by positive results from the Phase III B-Well 1 and B-Well 2 trials, in which bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. The drug candidate also showed an acceptable safety and tolerability profile consistent with previous studies.

Chronic hepatitis B affects more than 250 million people globally and nearly one million people in Japan.

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