Cadila Pharma announced the launch of generic Obeticholic Acid (Ocaliva), a generic version of Ocaliva (Obeticholic Acid), in India. The molecule is used to treat primary biliary cholangitis (PBC).
For the treatment of PBC, currently, Ursodeoxycholic acid (UDCA) is being extensively used. Obetocad can be used as a monotherapy or along with UDCA for treatment of patients who are unresponsive to UDCA therapy.
“There is an unmet need in the treatment of PBC. Ursodeoxycholic acid is the only approved standard of care but a major chunk of the patients do not respond to the treatment. Obetocad containing Obetocholic Acid is now DCGI approved and shows positive results in patients. This generic drug is launched for the first time in the country, and with Obetocad, we hope to provide an option to all the patients of PBC” shared Narendra Deode, VP, Cadila Pharmaceuticals.
Obetocad is available in 5 mg and 10 mg tablets in packs of 10 tablets. It is also USFDA and EMA approved and recently received its DCGI approvals. Obetocad also has the potential to be used in other indications such as NASH, NAFLD, severe acute hepatitis, bile acid diarrhoea, bariatric and gallstone diseases.