Shilpa Medicare Limited has announced that it has received approval from the Central Drugs Standard Control Organization (CDSCO) for its Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). According to the company, this is the first approval for NorUDCA for NAFLD anywhere in the world.
NAFLD is one of the most common liver conditions globally, affecting about 25% of the world’s population, which is roughly 1.2 billion people. In India, the estimated patient population is around 188 million. If not addressed in time, NAFLD can progress to non-alcoholic steatohepatitis (NASH) and lead to serious liver complications.
NorUDCA is described as having choleretic and anti-inflammatory properties, which can help improve bile flow, reduce inflammation in the liver, and potentially slow the progression of NAFLD and related liver disorders. Data from studies referenced by the company indicate that NorUDCA showed better results compared to placebo, with improvements in liver structure and function and no significant safety issues reported.
The approval allows Shilpa Medicare to make NorUDCA available in India for NAFLD treatment. The company has stated that it aims to address an existing treatment gap for patients with this condition.
