Gilead strengthens seladelpar case in PBC

US biotech major Gilead Sciences (Nasdaq: GILD) has announced two-year interim results from the ongoing ASSURE study of investigational seladelpar for the treatment of primary biliary cholangitis (PBC), a rare, chronic inflammatory liver disease.

A New Drug Application (NDA) for the oral, selective PPAR-delta to treat PBC, including pruritus, in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid, has been accepted for priority review by the US Food and Drug Administration (FDA).

"Seladelpar may meaningfully raise the bar in PBC"An FDA decision is due in August, and the UK Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency have also accepted seladelpar for review.