Posted by Michael Wonder on 02 Mar 2017
NICE recommends Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cholangitis in England, Wales and Northern Ireland
2 March 2017 - Rapid NICE approval only two months after marketing authorisation in the EU; one of the fastest approvals to date for an orphan medicine.
Intercept Pharmaceuticals today announced that the NICE has approved Ocaliva (obeticholic acid) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland.
Ocaliva has been conditionally approved in the European Union for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
The NHS is expected to make Ocaliva available to patients with PBC within 90 days of NICE's final appraisal publication and Intercept will work with local reimbursement authorities to help ensure eligible patients obtain access.
