Biopharmaceutical company GSK PLC (LSE: GSK)) (NYSE: GSK) announced on Monday that the European Medicines Agency has accepted its marketing authorisation application for linerixibat, a targeted ileal bile acid transporter (IBAT) inhibitor, for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).

The submission is based on positive data from the phase III GLISTEN trial, which met both primary and key secondary endpoints, demonstrating significant and sustained improvement in pruritus severity and itch-related sleep disruption. The safety profile was consistent with previous studies of IBAT inhibition.

Cholestatic pruritus, an intense internal itch affecting up to 90% of PBC patients, is currently underserved by existing therapies. Linerixibat, which has orphan drug designation in the US and EU, is currently under regulatory review in the US and UK but is not yet approved in any market.

GSK continues to expand its hepatology pipeline, with ongoing research into chronic hepatitis B, alcohol-related liver disease and metabolic dysfunction-associated steatohepatitis.