Dr Reddy’s Labs launches generic obeticholic acid in India

Dr Reddy’s Labs launches generic obeticholic acid in India

The pharmaceutical company Dr Reddy’s Laboratories has launched the generic version of the first-in-class farnesoid X receptor agonist, obeticholic acid (Ocaliva) in India for the treatment of primary biliary cholangitis (PBC).

The drug which is named FXR is recommended to be used either in combination with ursodeoxycholic acid (UDCA) or as monotherapy in adults with PBC. FXR will be available in strengths of 5mg and 10mg tablets.

PBC is a rare chronic autoimmune disease, characterised by the destruction of small bile ducts in the liver. The only approved treatment for PBC in India as of now is UDCA, as the first-line treatment for PBC, although up to 40% of the patients do not respond to the treatment, the company said in a statement.