Shilpa Secures SEC, CDSCO Approval for New IND Tablets in NAFLD
Shilpa Medicare has received approval from India’s top drug authorities to move forward with its new IND - Nor-Ursodeoxycholic Acid (500 mg).
This approval is for treating non-alcoholic fatty liver disease (NAFLD), a common liver condition that affects about one in four people worldwide—roughly 1.2 billion people—including 188 million in India. If NAFLD isn’t treated, it can get worse and lead to more serious liver problems that may be life-threatening. This new medicine offers hope for better treatment options for people with NAFLD.
Shilpa Medicare completed a major clinical trial of its new NAFLD treatment in 165 patients across India. The study showed the medicine was safe and well tolerated, with no serious side effects. After 24 weeks, 83% of patients saw their liver scarring improve, and about 90% had key liver enzyme levels return to normal within 12 weeks. These results suggest this medicine could set a new standard for treating fatty liver disease in India
Commenting on the development, Vishnukant Bhutada, Managing Director, Shilpa said, “We are very pleased with this approval from SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, ‘Innovating for affordable healthcare’ keeping in mind the unmet needs of a large patient pool. 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.”
