Source: Sharecast
For hepatitis B, Japan's Ministry of Health, Labour and Welfare accepted the company's filing for bepirovirsen, supported by "statistically significant" functional‑cure rates in the Phase III B‑Well trials. GSK said the data showed higher cure rates when the drug was used alongside standard of care compared with standard of care alone.
The treatment, aimed at the nearly one million people in Japan living with chronic hepatitis B, has been granted SENKU designation for expedited review and has shown an acceptable safety and tolerability profile consistent with earlier studies.
Over in China, the National Medical Products Administration accepted GSK's application for linerixibat, an investigational therapy for cholestatic pruritus in primary biliary cholangitis.
The submission was backed by positive Phase III GLISTEN trial results, which demonstrated significant and sustained improvements in pruritus and sleep disturbance versus placebo. GSK noted that around 280,000 people in China are affected by PBC, with up to 89% experiencing cholestatic pruritus.
Linerixibat already holds Orphan Drug Designation in the US, EU and Japan, with marketing applications also under review in the US, EU, UK and Canada.
As of 1005 GMT, GSK shares were down 0.54% at 2,202p.
Reporting by Iain Gilbert at Sharecast.com