The Subject Expert Committee (SEC) of India’s Central Drugs Standard Control Organisation (CDSCO) has approved an IND for Shilpa Medicare’s Nor Ursodeoxycholic Acid (Nor-UDCA) 500 mg tablets (SMLNUD07) to treat non-alcoholic fatty liver disease (NAFLD), or metabolic dysfunction-associated steatotic liver disease (MASLD).
The committee also recommended granting marketing authorization for the therapy in India. The approval and recommendation were based on the positive data from the Phase III trial. Shilpa Medicare “hopes to obtain marketing approval soon”, with plans to launch the treatment in the country in the “coming financial year”.
The company’s managing director, Vishnukant Bhutada added: “Based on the approval in India, we plan to reach out to Global regulatory authorities to seek scientific advice for introduction of this novel product internationally.”
Phase III trial results
Nor-UDCA is a side chain-shortened C23 homologue of the C24 bile acid ursodeoxycholic acid. It has shown promising results in preclinical studies in reducing inflammation, fibrosis, and apoptosis (cell death).
The placebo-controlled Phase III trial evaluated the safety and efficacy of 1500mg of Nor-UDCA in 165 NAFLD patients across India. The study met all its primary efficacy endpoints by showing a significant improvement in the fatty liver stage. At 12 weeks, elevated alanine transaminase (ALT) levels of NAFLD were normalized in 90% of the participants in the treatment arm, the trial’s primary endpoint.
The company noted that liver fibrosis stage was reversed in 83.3% of the participants receiving Nor-UDCA and stabilized in the rest, within 24 weeks. No serious adverse events were reported, and the treatment was well tolerated at the dose of 1500 mg per day for 24 weeks.
NAFLD is one of the most common liver diseases, with an estimated global incidence of 47 cases per 1,000 population. There are no specifically approved medications for NAFLD, with its management primarily focusing on lifestyle modifications.
