GSK (GSK) said Monday that the European Medicines Agency has accepted for review the marketing authorization application for its experimental drug, linerixibat, to treat cholestatic pruritus in patients with primary biliary cholangitis, a rare autoimmune liver condition.
The drugmaker said the submission is backed by a phase 3 trial that showed the drug significantly improved cholestatic pruritus and itching-related sleep disruption compared to placebo.
Linerixibat is not yet approved in any country, it added.
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