Shilpa Medicare announces the approval of its IND - Nor Ursodeoxycholic Acid Tablets 500 mg, by the Subject Expert Committee of CDSCO. The Committee has further recommended grant of marketing authorization for this IND for the treatment of non-alcoholic fatty liver disease (NAFLD).
Shilpa Medicare Ltd. had earlier completed phase-3 clinical studies of this novel product SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets - and presented the results of the trial titled “A phase - III, Randomized, Double- Blind, placebo controlled, multicenter, Parallel group study” to evaluate the safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients suffering from Non-alcoholic Fatty Liver Disease to the SEC.
This trial was a multicentric, placebo controlled double blinded study conducted on total 165 Non-alcoholic fatty liver disease (NAFLD) patients across India – a significant statistically powered number of patients leading to better reliability of data and results. No serious adverse events were reported in this phase 3 study and the treatment was well tolerated at the dose of 1500 mg per day for the duration of 24 weeks.
The Phase 3 trial has met all the primary efficacy endpoints set in the clinical trial protocol, demonstrating a significant improvement in fatty liver stage. In this study 165 participants were randomised to assess and compare the efficacy and safety of nor UDCA 1500 mg against placebo. The data analysis has confirmed that liver fibrosis stage was reversed in significant majority of participants (83.3%) and stabilised in rest, within 24 weeks of nor UDCA treatment. (Primary endpoint) The elevated alanine transaminase (ALT) levels of NAFLD were normalized in significant proportion of participants (
90%) within 12 weeks of study (Primary endpoint).
These results indicate that Nor UDCA could become a new standard of care with significant improvements in restoring liver function in NAFLD patients. This IND is expected to revolutionise the treatment of patients suffering from Nonalcoholic Fatty Liver Disease (NAFLD).