Dr. Reddy’s Laboratories Ltd., today announced the launch of 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 , 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.
Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses-
Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr Reddy's major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe and major ones include – USA, India, Russia & CIS countries, and Europe.