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Dr. Reddy’s Laboratories Ltd has launched FXR a therapeutic equivalent generic version of Ocaliva (obeticholic acid) in India.
Ocaliva is a trademark of Intercept Pharmaceuticals. The drug is indicated for the treatment of Primary Biliary Cholangitis (PBC), in combination with Ursodeoxycholic Acid (UDCA) or as monotherapy in adults.
“We are excited to be the first generic company to market Obeticholic Acid in India,” MV Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr Reddy’s Laboratories, said in a release.
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,” he added.
Hyderabad-based 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 per cent 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., the company said.
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