FDA approva Lynavoy (linerixibat) per il prurito colestatico associato a PBC. In EMA è attesa la CHMP opinion
US Food and Drug Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication. Up to 89% of people living with PBC experience cholestatic pruritus, an internal itch with a debilitating impact on quality of life.
GSK previously announced on 9 March a licence agreement under which Alfasigma S.p.A. will acquire worldwide exclusive rights to develop, manufacture and commercialise linerixibat. This transaction is ongoing and is subject to customary conditions, including applicable regulatory agency clearances such as under the Hart-Scott-Rodino Act in the US.
The approval is based on data from the global GLISTEN phase III trial which met both primary and key secondary endpoints, demonstrating significant, rapid (at week two) and sustained (over 24 weeks) improvements in cholestatic pruritus and itch-related sleep interference versus placebo. GLISTEN phase III trial regulatory reviews are underway in the EU, UK, Canada and China.
Linerixibat has been granted Orphan Drug Designation in the US, EU and Japan, and priority review in China, for the treatment of cholestatic pruritus in patients with PBC. Marketing applications for linerixibat are ongoing in the EU, UK, Canada and China.
Lynavoy USPI
Lynavoy in CHMP Mar 23-26 agenda