Dr. Reddy’s Laboratories Ltd., today launched FXR a therapeutic equivalent generic version of Ocaliva (obeticholic acid) in India, indicated for the treatment of Primary Biliary Cholangitis (PBC), in combination with Ursodeoxycholic Acid (UDCA) or as monotherapy in adults.
Commenting on the launch, M V Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s Laboratories said, “We are excited to be the first generic company to market Obeticholic Acid in India. The launch of FXR, the first-in-class Farnesoid X receptor agonist represents Dr. Reddy’s expertise to accelerate access to affordable alternatives for complex products. FXR™ will be an important addition to our Hepatology portfolio.”
Dr. Reddy’s FXR is available in strengths of 5mg and 10mg tablets.
PBC, is a rare chronic autoimmune disease, characterised by destruction of small bile ducts in the liver. The only approved treatment for PBC in India as of today is UDCA, which was approved almost two decades ago. Though considered as a first line treatment for PBC, up to 40% of the patients do not respond to UDCA treatment, leaving many PBC patients with no approved treatment option. In 2016, Obeticholic acid received accelerated approval for the treatment of PBC as an ‘orphan drug’ in the U.S.