NASH is a hepatic manifestation of increased triglyceride accumulation in the liver leading to inflammation, fibrosis, cirrhosis and liver failure. NASH ranks as one of the major causes of Liver Transplant in United States and Europe, after hepatitis C. Biotech Analysts estimate the worldwide market for NASH medicines to reach USD 35-40 billion by 2025.
Speaking on the announcement, Mr. Pankaj R. Patel, Chairman and Managing Director, Zydus Cadila said, "The study results have demonstrated that Saroglitazar has anti-fibrotic effect combined with strong efficacy in reducing fat and inflammation from the liver. The economic and clinical burden of nonalcoholic fatty liver disease (NAFLD) is rising exponentially and currently there is no approved treatment for NASH. Zydus is committed to developing Saroglitazar as a potential treatment option for millions of patients suffering from NASH."
Saroglitazar (Lipaglyn™), a novel PPARα/γ agonist having predominant PPAR alpha activity, was launched in India as a prescription medicine for the treatment of Hypertriglyceridemia and Diabetic Dyslipidemia in Patients with Type 2 Diabetes not controlled by statins. Since its launch in September 2013, more than 300,000 patients have been treated with Lipaglyn™ in India, and data has been presented at several scientific and medical conferences.
Saroglitazar is currently being evaluated in several clinical trials, including the Biomarkers driven Non-invasive Phase 2 "EVIDENCES-II" clinical study in USA, and a separate Biopsy-driven Phase 3 trial "EVIDENCES-III" in patients with NASH in India and other countries.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. For more information, please visit http://www.zyduscadila.com
SOURCE Zydus Cadila