GSK announces that the European Medicines Agency (EMA) has agreed to review the marketing authorization application (MAA) for linerixibat for the treatment of pruritus in patients with primary biliary cirrhosis (PBC).

This acceptance follows that of the FDA earlier this month.

The application is based on positive results from a Phase III trial presented in May at the EASL Congress, which met its primary and secondary endpoints, demonstrating rapid, significant, and sustained improvement in pruritus and associated sleep disturbances.

The tolerability profile was consistent with previous studies.

To date, linerixibat has not been approved in any country, the company notes.


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