Dr. Reddy’s Laboratories announces the launch of FXR™(obeticholic acid)in India

Hyderabad, India, May 18,2020—Dr. Reddy’s Laboratories Ltd., today announced the launch of FXR™, atherapeutic equivalentgeneric version of Ocaliva® (obeticholic acid) in India,indicated for the treatment of Primary Biliary Cholangitis(PBC), in combination with UrsodeoxycholicAcid (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 firstgenericcompany tomarket ObeticholicAcid in India. The launch of FXR™, the first-in-class Farnesoid X receptor agonistrepresents Dr. Reddy’s expertise to accelerate access to affordable alternatives for complex products. FXR™will be an important addition toour Hepatologyportfolio.”Dr. Reddy’s FXR™is available in strengthsof 5mg and10mg 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 twodecades 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 PBCas an ‘orphan drug’inthe U.S.Ocaliva®is a trademark ofIntercept Pharmaceuticals.