CALT - Calliditas' setanaxib nabs Fast Track tag in U.S. for chronic liver disease

The FDA has granted Fast Track Designation to Calliditas Therapeutics' (NASDAQ:CALT) lead NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis (PBC). Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application. Setanaxib has previously been granted orphan drug designation for PBC in the U.S. and Europe. In a Phase 2 trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue. Following positive results from a Phase 1 study conducted in 2020, teh company is planning to initiate a Phase 2/3 study in PBC, starting in H2 2021.

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Calliditas' setanaxib nabs Fast Track tag in U.S. for chronic liver disease