Torrent, Zydus in co-marketing pact for liver disease drug Saroglitazar
Zydus starts trial to generate data on effect of Saroglitazar Mg in NAFLD patients
China is expected to record the highest diagnosed prevalence of non-alcoholic fatty liver disease (NAFLD) in 2029, representing 44% of cases within the 16 major pharmaceutical markets (16MM). As a result, the number of clinical trials conducted in the country for this indication is gradually increasing, driven mostly by international pharmaceutical companies, but lacks substantial participation from domestic firms, says GlobalData, a leading data and analytics company.
Positive results from the phase-II(a) clinical trial evaluating Saroglitazar Mg in patients with NASH were published nin the Journal of Hepatology
Zydus today received permission from the US Food and Drug nAdministration (FDA) to initiate the phase-II(b)/III prospective, nmulti-centre, randomised, double-blind, placebo-controlled adaptive nclinical trial to evaluate the efficacy and safety of Saroglitazar nMagnesium in subjects with Primary Biliary Cholangitis (PBC), the ncompany said in a statement.
European Medicines Agency grants Orphan Drug Designation to Zydus Cadila`s Saroglitazar Mg
Zydus Cadila, an innovation-driven global pharmaceutical company today announced that the DrugController General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar Mg for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) in India. The prevalence ofnNAFLD in India is estimated to be nearly 25-30% of the general population. This approval fornNAFLD alongwith either of the comorbidities (Obesity, Type 2 Diabetes Mellitus, Dyslipidemia ornMetabolic Syndrome) provides the physicians with a viable treatment option. With a once daily, 4mg dose regimen, Saroglitazar Mg will enable better compliance, reduces the pill burden and offers the patient more convenience.
New Delhi: Drug firm Zydus Cadila on Wednesday said it has received approval from the Drug Controller General of India (DCGI) for Saroglitazar Mg, used for the treatment of non-alcoholic fatty liver disease (NAFLD), in the country. The Drug Controller General of India (DCGI) has approved the new drug application (NDA) for Saroglitazar Mg for the treatment of non-alcoholic fatty liver disease (NAFLD) in India, Zydus NSE -0.79 % Cadila said in a regulatory filing
Zydus announced that a Late-Breaker Oral Presentation and two Poster Presentations on Saroglitazar Mg has been accepted for presentation at The Liver Meeting 2020, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place virtually from November 13-16, 2020.
Zydus Cadila, an innovation-driven global pharmaceutical company, today 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.