The EMA has started a review of GSK's treatment candidate for primary biliary cholangitis (PBC), linerixibat, offering hope ...

GSK plc (LSE/NYSE:GSK) a annoncé lundi que l'Agence européenne des médicaments (EMA) a accepté d'examiner sa demande d'autorisation de mise sur le marché pour le linerixibat, un traitement expérimenta ...

EMA accepts GSK’s MAA for linerixibat for cholestatic pruritus in patients with primary biliary cholangitis: London, UK Tuesday, June 24, 2025, 09:00 Hrs [IST] GSK plc announced ...

– GSK a annoncé lundi que l’Agence européenne des médicaments a accepté d’examiner la demande d’autorisation de mise sur le ...

Le linerixibat agit en inhibant le transporteur iléal des acides biliaires (IBAT), réduisant les médiateurs du prurit en circulation. La FDA et l’EMA ont toutes deux accordé au médicament la ...

GSK annonce que l'Agence européenne des médicaments a accepté d'examiner la demande d'autorisation de mise sur le marché du ...

The FDA has accepted for review the NDA for linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis.

(Alliance News) - GSK PLC on Monday said linerixibat has been accepted for review by the European Medicines Agency for the treatment of intense itching caused by a rare autoimmune liver disease.

Linerixibat was also associated with significant improvements in key secondary endpoints vs placebo, including itch score at week 2 (P <.001) and itch-related sleep interference over 24 weeks (P ...

Linerixibat has not yet been approved in any market, but both the FDA and the European Medicines Agency have granted it orphan drug designation for treating cholestatic pruritus in PBC patients.