Shilpa Medicare Limited has received approval from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for its IND – Nor Ursodeoxycholic Acid Tablets 500 mg. The SEC has also recommended granting marketing authorization for the drug, aimed at treating non-alcoholic fatty liver disease (NAFLD).
NAFLD is among the most prevalent liver diseases worldwide, affecting nearly 1.2 billion people globally and approximately 188 million patients in India. If left untreated, it can progress to non-alcoholic steatohepatitis (NASH), a condition with potentially severe health consequences.
Shilpa Medicare had earlier conducted a Phase-3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of Nor-Ursodeoxycholic Acid (Nor UDCA) 500 mg. The study was conducted on 165 NAFLD patients across India and demonstrated no serious adverse effects, with the treatment being well-tolerated at a daily dose of 1500 mg for 24 weeks.
Clinical trial highlights:
- 83.3% of participants showed reversal of liver fibrosis within 24 weeks of treatment.
- 90% of patients experienced normalization of elevated alanine transaminase (ALT) levels within 12 weeks.
- The trial successfully met its primary efficacy endpoints, supporting its potential as a new treatment standard.
Shilpa Medicare’s Nor UDCA offers significant advantages over traditional UDCA, including enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and reduced fibrosis. If approved for commercialization, it would be the first-in-class treatment for NAFLD in India.
Expansion plans:
The company plans to initiate regulatory approvals in Europe and the USA, aiming for international expansion of this novel treatment.
Commenting on the development, Vishnukant Bhutada, Managing Director of Shilpa Medicare, stated,
“We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible. Based on the approval in India, we plan to seek regulatory advice for introducing this product globally.”
About Shilpa Medicare:
Shilpa Medicare is an integrated pharmaceutical group specializing in Oncology & Non-oncology APIs, Peptides, Polymers, and differentiated finished dosage formulations. The company also provides end-to-end CDMO services with four R&D units and seven manufacturing facilities.
