Calliditas Receives the US FDA’s Fast Track Designation for Setanaxib to Treat Primary Biliary Cholangitis

August 9, 2021 Auto Bot Fast Track Designation, FDA, regulatory 0

Shots:

  • The US FDA has granted FTD to selinexor (NOX inhibitor) for the treatment of PBC. Additionally, the therapy has previously received ODD for PBC in the US & EU
  • The P-II clinical trial of the therapy demonstrated anti-fibrotic activity as measured by Fibroscan and showed favorable tolerability profile along with the impact on fatigue
  • The company plans to start P-II/III study for PBC in H2’21 based on results from the P-I study which evaluated higher doses of setanaxib in healthy volunteers

Click here to­ read full press release/ article | Ref: Calliditas | Image: Calliditas

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