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Shilpa Medicare's Novel NAFLD Treatment Receives CDSCO Approval Following Successful Phase 3 Trial

  • Shilpa Medicare has secured CDSCO approval for Nor Ursodeoxycholic Acid (500mg) tablets to treat non-alcoholic fatty liver disease, addressing a condition affecting 190 million Indians.

  • Phase 3 clinical trials demonstrated remarkable efficacy with 83.3% of patients showing liver fibrosis reversal and 90% achieving liver function improvement within 12 weeks.

  • The company plans to pursue regulatory approvals in the EU and USA following successful commercialization in India, signaling potential global expansion.

Indian pharmaceutical company Shilpa Medicare has achieved a significant milestone in liver disease treatment with the Central Drugs Standard Control Organisation (CDSCO) granting approval for its Nor Ursodeoxycholic Acid (Nor UDCA) tablets. This breakthrough therapy targets non-alcoholic fatty liver disease (NAFLD), a condition affecting approximately 190 million people in India alone.

Promising Clinical Trial Results

The approval follows successful Phase 3 trials of SMLNUD07 (Nor UDCA) involving 165 NAFLD patients in India. The study demonstrated impressive efficacy and safety profiles at a daily dosage of 1500 mg administered over 24 weeks. Most notably, 83.3% of patients experienced liver fibrosis reversal, while the remaining participants showed disease stabilization.
The trial revealed rapid improvement in liver function, with 90% of patients achieving ALT normalization within just 12 weeks of treatment. Importantly, the medication showed no serious adverse effects throughout the study period, establishing a favorable safety profile.

Addressing a Global Health Crisis

NAFLD represents a significant global health burden, affecting approximately 25% of the world's population. Without proper treatment, patients face the risk of progression to non-alcoholic steatohepatitis (NASH), a more severe form of liver disease with potentially life-threatening complications.

Strategic Commercial Plans

The Subject Expert Committee of CDSCO has recommended the drug for marketing approval in India, paving the way for commercial launch. Vishnukant Bhutada, Managing Director of Shilpa Medicare, expressed optimism about the company's international expansion plans, stating their intention to pursue regulatory approvals in the European Union and United States markets following the Indian launch.

Treatment Protocol

The approved formulation consists of 500 mg tablets, with clinical trials validating a therapeutic regimen of 1500 mg daily. This new treatment option represents a significant advancement in NAFLD management, offering hope to millions of patients worldwide.
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