A cluster of recent breakthrough therapy designation awards in liver disease highlight advances in the field ahead of the US Food and Drug Administration’s difficult, and now delayed, decision on the future of Intercept’s Ocaliva (obeticholic acid) under accelerated approval in primary biliary cholangitis.
After Ocaliva: US FDA Sees Breakthrough Potential In New Approaches To Liver Disease
New nods for Boehringer Ingelheim’s survodutide, Sagimet’s denifanstat and Mirum’s volixibat bring the FDA’s non-infectious liver disease breakthrough therapy designations to 15, with six designees already approved.
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