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Cloud hangs over drug's future

Posted 17 September 2024 AM

The future of Ocaliva could be in jeopardy with regulators overseas calling into question the effectiveness and safety of the primary biliary cholangitis (PBC) treatment.

Ocaliva, marketed in Australia by Chiesi, was granted full approval in 2018 for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

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