#India #NASH #Shilpa Medicare #Nor-UDCA #Raichur

Shilpa Medicare Secures Approval for Nor-UDCA Tablets

In a significant milestone for the pharmaceutical industry, Shilpa Medicare Limited, a prominent manufacturer of active pharmaceutical ingredients (APIs) and formulations, has successfully received approval from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for its experimental drug, Nor-Ursodeoxycholic Acid (Nor-UDCA). This development paves the way for an anticipated market launch focused on treating Non-Alcoholic Steatohepatitis (NASH).

Understanding NASH

NASH, which stands for Non-Alcoholic Steatohepatitis, represents a severe liver condition that affects approximately 25% of the global population—roughly 1.2 billion people. In India alone, around 188 million individuals are afflicted. This condition can escalate from Non-Alcoholic Fatty Liver Disease (NAFLD) into NASH, a severe stage that can lead to liver failure or even death if left untreated. Given that NASH's prevalence is on the rise, effective treatments are urgently needed.

Clinical Trial Success

Shilpa Medicare's journey with Nor-UDCA has been marked by rigorous testing and evaluation. The company has successfully completed Phase 3 clinical trials under the product designation SMLNUD07 and presented the results to the SEC. The trials conducted were multicentric, randomized, and double-blind, aimed at assessing the safety and efficacy of Nor-UDCA 500 mg tablets among patients with NASH.

The trial results met all primary efficacy endpoints, demonstrating a significant reduction in liver steatosis progression. Some noteworthy outcomes include:

• - Liver Fibrosis Regression: An impressive 83.3% of trial participants experienced a regression in fibrosis, while others maintained stability.
• - ALT Normalization: High levels of alanine aminotransferase (ALT)—a key biomarker for liver diseases—normalized in about 90% of participants within 12 weeks.

These findings position Nor-UDCA as a potential game-changer for patients suffering from NASH, offering distinct advantages over traditional Ursodeoxycholic Acid (UDCA). The novel drug boasts enhanced choleretic effects, resilience to amidation, anti-inflammatory properties, and potential benefits in fibrosis reduction.

Future Outlook

Commenting on this significant approval, Mr. Vishnukant Bhutada, the Managing Director of Shilpa Medicare Limited, expressed enthusiasm for this pivotal moment. He conveyed optimism about the swift market authorization, emphasizing the company's commitment to working closely with regulatory authorities to expedite access to this innovative treatment for patients.

“We are dedicated to addressing the unmet needs of many patients and are hopeful of launching this product in India within the forthcoming fiscal year,” Bhutada stated. The approval further augments Shilpa’s reputation in the industry, showcasing their motto, "Innovate for affordable healthcare."

Looking ahead, Shilpa Medicare plans to engage with global regulatory authorities to seek scientific guidance for an international launch of Nor-UDCA, thereby broadening its reach and impact.

Founded in 1987, Shilpa Medicare is recognized for its comprehensive and turnkey pharmaceutical solutions. With facilities accredited by leading global regulatory bodies, the company is well-equipped to meet the evolving healthcare demands and challenges.

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