Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has completed enrollment in EVIDENCES II, EVIDENCES III and EVIDENCES V Phase 3 clinical trials of Saroglitazar Mg for treating Non-Alcoholic SteatoHepatitis (NASH). Patients with NASH have been enrolled in these trials across clinical sites in India and Mexico.
Speaking on the development Mr. Pankaj R. Patel, Chairman, Zydus group said, “We are excited about the progress that Saroglitazar Mg has been making in the NASH trials. It is currently being evaluated in over 23 different controlled clinical trials, involving over 3,800 patients. NASH is an area of unmet healthcare need and we are committed to develop this therapy for millions of patients suffering from this deadly disease.”
EVIDENCES II is a Phase 3 biopsy-driven trial of Saroglitazar 4 mg versus Placebo in patients with Non-Alcoholic SteatoHepatitis. The primary endpoint will be evaluated by histological improvement of NASH using liver biopsy at the end of 52 weeks. EVIDENCES III is the prospective, multicenter, randomized, double-blind study of Saroglitazar 4 mg versus Placebo in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). This trial will measure the change in liver fat content as measured by non-invasive magnetic resonance imaging (MRI) at week 24. Several other secondary endpoints including Liver stiffness as measured by transient elastography/FibroScan and Serum alanine aminotransferase (ALT) level will also be evaluated.
EVIDENCES V will evaluate the NASH patients over a period of 18 months, measure the change in the liver fat content by magnetic resonance imaging-derived proton density-fat fraction (MRIPDFF) at Week 24 and evaluate the liver biopsy driven endpoints of Saroglitazar 4 mg from baseline to Week 76. Saroglitazar Magnesium was launched in India during September 2013, for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with type-2 diabetes not controlled by statins. Saroglitazar Mg has demonstrated beneficial effects in NASH animal models. Saroglitazar Mg favorably affects all components of NASH including steatosis, ballooning, inflammation and fibrosis in NASH models. Saroglitazar Mg has previously demonstrated improvement in both liver enzymes along with favorable effects on lipid and glycemic indices in patients with nonalcoholic fatty liver disease in Phase II clinical trials.
NASH is a progressive disease of the liver and a significant unmet medical need. Starting with fat accumulation in liver, this condition can progress to cirrhosis and liver failure. 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. There are currently no treatments available for the treatment of NASH.
Zydus’ Nesher Pharmaceuticals receives final approval from the USFDA for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate ER Capsules
Zydus’ Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the USFDA to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, ExtendedRelease Capsules (US RLD – ADDERALL XR®), 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg. The drug is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) which is a brain disorder characterized by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. It will be manufactured at Nesher Pharmaceuticals’ manufacturing facility located at St. Louis, MO, USA. The group now has 269 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04.