India's pharmaceutical company Morepen Laboratories has secured a significant regulatory milestone in its pursuit to develop a novel treatment for fatty liver disease. The Subject Expert Committee (SEC) of India's Central Drugs Standard Control Organization (CDSCO) has granted clearance for the company to conduct Bioequivalence (BE) studies for Resmetirom tablets in three dosage strengths - 60mg, 80mg, and 100mg.
This regulatory approval marks a critical step in Morepen's drug development process, positioning the company among the first Indian pharmaceutical firms prepared for the global launch of this promising therapy. Following the bioequivalence studies, Morepen will proceed with clinical trials according to approved protocols.
Understanding NASH: A Growing Global Health Concern
Resmetirom targets non-alcoholic steatohepatitis (NASH), a severe form of non-alcoholic fatty liver disease (NAFLD) characterized by inflammation, liver damage, and fat accumulation in the liver. If left untreated, NASH can progress to serious complications including fibrosis, cirrhosis, and hepatocellular carcinoma.
The condition affects over 115 million people worldwide and is often associated with obesity, metabolic syndrome, and type 2 diabetes. NASH frequently remains asymptomatic in its early stages, making it a silent disease until significant liver damage has occurred.
"This is a critical step forward in our journey to bring a much-needed innovation to the hepatology market," said Sanjay Suri, Executive Director at Morepen Laboratories, highlighting the significance of this development for patients suffering from this progressive liver condition.
Market Potential and Growth Projections
Industry analysts project substantial growth for the NASH treatment market, with estimates suggesting an expansion from $2.5 billion in 2024 to over $16 billion by 2032. This growth trajectory is driven by increasing disease prevalence, rising clinical awareness, and anticipated regulatory approvals for novel therapies.
Morepen's early entry into this therapeutic area could provide the company with a competitive advantage in the rapidly evolving specialty and chronic care segments. The company's integrated capabilities—spanning from API production to finished dosage formulations—position it favorably to capitalize on this market opportunity.
Morepen's Strategic Position
With over four decades of operational experience, Morepen currently exports pharmaceutical products to more than 80 countries worldwide. The company manufactures active pharmaceutical ingredients (APIs) at FDA-approved facilities, demonstrating its commitment to maintaining high quality standards.
The development of Resmetirom aligns with Morepen's strategy to strengthen its leadership in the Indian pharmaceutical landscape while expanding its global footprint. By targeting NASH—a disease with significant unmet medical needs—Morepen is addressing a critical gap in current treatment options.
Therapeutic Mechanism and Potential Impact
While specific details about Resmetirom's mechanism of action weren't disclosed in the announcement, the drug represents a promising approach to addressing the underlying pathophysiology of NASH. Current management strategies for NASH primarily focus on lifestyle modifications and treating associated conditions, with limited pharmacological options specifically approved for NASH.
The introduction of Resmetirom could potentially transform the treatment landscape for patients with NASH, offering a targeted therapeutic approach to this complex liver disease. As clinical trials progress, healthcare professionals and patients will gain further insights into the efficacy and safety profile of this investigational therapy.
The company's shares were trading at ₹62.36, up by ₹0.31 or 0.50 percent on the NSE following the announcement, reflecting positive market sentiment toward this development.
