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GSK plc (LSE/NYSE:GSK) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for linerixibat, an investigational oral treatment targeting cholestatic pruritus in patients with primary biliary cholangitis (PBC). This condition, characterized by a relentless itch, affects individuals with this rare autoimmune liver disease. The FDA has set March 24, 2026, as the Prescription Drug User Fee Act (PDUFA) goal date for its decision.
The NDA submission is supported by data from the GLISTEN phase III trial, which demonstrated significant improvements in pruritus and itch-related sleep interference compared to placebo. The trial’s results were presented in May at the European Association for the Study of the Liver Congress. Linerixibat, an ileal bile acid transporter (IBAT) inhibitor, aims to reduce bile acid re-uptake, addressing the underlying cause of the itch.
Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology & Inflammation R&D at GSK, stated, "The FDA’s acceptance of this file is an important milestone in the development of linerixibat. We believe that linerixibat has the potential to make a difference in the lives of patients living with relentless itch associated with PBC and its related sleep interference."
Cholestatic pruritus can be a debilitating symptom for those with PBC, affecting up to 90% of patients and often leading to sleep disturbance and impaired quality of life. Current treatments for PBC do not effectively address the itch, underscoring the need for new therapeutic options.
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.
This information is based on a press release statement from GSK plc, filed with the U.S. Securities and Exchange Commission.
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