Zydus Announces World’s First Drug for the Treatment of Non-Cirrhotic NASH

▴ Zydus Announces Worlds First Drug for the Treatment of NonCirrhotic NASH
Saroglitazar, approved by DCGI becomes the first ever drug anywhere in the world for treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH). NASH ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease and is a leading cause of liver transplant.

Zydus Cadila, an innovation-driven global pharmaceutical company recently announced that the Drug Controller General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar for the treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) in India.


NASH is a progressive disease of the liver, which starts with fat accumulation in the liver known as Non-Alcoholic Fatty Liver Disease (NAFLD). This condition could progress to cirrhosis and liver failure. It is a large unmet medical need as there is currently no approved drug for the treatment of NASH anywhere in the world, a disease that is highly prevalent with 10% to 30% of the global population being affected by it. The prevalence of NASH in India is estimated to be nearly 25% of the population. NASH ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease. Liver transplantation is the only option for managing advanced cirrhosis with liver failure.


Speaking about the development, Pankaj Patel, Chairman, Zydus Group mentioned, “We are happy that our efforts to discover and develop a novel drug for patients living with NASH, an unmet healthcare need globally have been successful. Saroglitazar will provide hope and new lease of life for millions of patients in India suffering from NASH.”

Saroglitazar was launched in India in September 2013, for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. In January this year, Saroglitazar received an approval for the treatment of Type 2 Diabetes Mellitus. In the last seven years, over a million patients have benefitted from this drug.


Saroglitazar is uniquely poised with its dual PPAR alpha and gamma properties – reducing the comorbidities (dyslipidemia, hypertriglyceridemia, diabetes mellitus) and causing NASH resolution. Zydus achieved positive results in EVIDENCES II trial, a Phase 3 liver biopsy trial of Saroglitazar 4 mg versus Placebo in Indian patients with NASH. The trial evaluated histological improvement of NASH using liver biopsy at the end of 52 weeks and successfully met primary and secondary endpoints. Saroglitazar 4 mg demonstrated a significant reduction in liver fat, liver enzymes and disease activity. 


In EVIDENCES I, which was a Phase 2 clinical trial, Saroglitazar demonstrated improvement in liver enzymes and lipids in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). On the global front, a Phase 2 trial (EVIDENCES IV) of Saroglitazar Mg in patients with NASH in the US met primary and secondary endpoints. The results were presented at The Liver Meeting 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) held at Boston.

Tags : #Zydus #Newdrug #Livertransplant

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Worldwide EndoMarch, Endo Run to raise mass awareness on Endometriosis!February 21, 2024
Uptick In Respiratory, and Cardiac Problems Due To Poor Air Quality In DelhiFebruary 21, 2024
Evidence shows risks associated with energy drinks in childrenFebruary 21, 2024
iHub-Data at IT-Hyderabad announces collaborative initiative with technical institutions for AI/ML training programsFebruary 20, 2024
Viatris Receives Global Minimized Risk of Antimicrobial Resistance Certification, Advancing its Commitment to Responsible Antibiotic ProductionFebruary 20, 2024
“Kusum Ka Biyaah” Indian Hindi film based on a true story releasing on 1st March 2024February 19, 2024
Introducing Moscow's Pioneering Initiative: An Open Dataset for AI-driven Brain Disease Detection"February 19, 2024
ICPA Health Products Introduces Coolora Spray - A Rapid Relief Solution For Oral & Throat DiscomfortFebruary 19, 2024
Section 43B of the Income Tax demystifiedFebruary 16, 2024
Nutricircle Introduces Health Supplements My45NutrientsTM to Enhance Overall Well-beingFebruary 16, 2024
YFLO organised a session “Design Your Story” to inspire young FICCI Ladies to design their own compelling storiesFebruary 15, 2024
149 experts call to find all TB to stop TBFebruary 15, 2024
ICPA Welcomes Global Leader In Periodontal Aesthetics - Prof Giovanni Zucchelli On His Inaugural Visit To IndiaFebruary 14, 2024
Fast Fashion and Sustainability are not friends and do not go well with each other: Namrata Joshipura, one of India’s most celebrated Fashion designers February 14, 2024
YFLO to organise a session Design Your StoryFebruary 14, 2024
Starkey Launches Genesis AI Hearing Aids in India, Pioneering a New Era in Hearing HealthFebruary 14, 2024
Indian Institute of Heritage and University of Birmingham announce strategic partnershipFebruary 14, 2024
Siddharth Anand’s Fighter emerges as the first hit of 2024February 13, 2024
India’s 26 years old youth’s Adventurous Atal Yatra to Celebrate Silver Jubilee of the Golden Quadrilateral beginsFebruary 13, 2024
Vitafoods India 2024 - Exploring Nutraceutical FrontiersFebruary 13, 2024