Zydus Cadila presents NDA for Saroglitazar Magnesium

New Delhi, December 5 () The pharmaceutical firm Zydus Cadila said Thursday that it filed a New Drug Application (NDA) with the Indian General Drug Controller (DCGI) for Saroglitazar Mg, used in the treatment of liver disease .

Zydus Cadila ... presented the NDA of Saroglitazar Mg in non-alcoholic steatohepatitis (NASH) before the Indian Comptroller General of Drugs (DCGI), the pharmaceutical firm said in a regulatory document.

NASH is a progressive disease of the liver and a significant unmet medical need. There are currently no treatments available for the treatment of NASH.

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.

There is a great need for new therapies for patients with NASH, who have no treatment options as their liver disease progresses, apart from opting for liver transplants to survive, said Zydus Group president Pankaj R. Patel.

Saroglitazar Mg has shown beneficial effects in NASH animal models, according to the presentation, adds that Saroglitazar Mg favorably affects all components of NASH, including steatosis, swelling, inflammation and fibrosis in NASH models.

We are very pleased that our NDA application has been accepted for review, which we believe represents an important step in providing an innovative treatment option for millions of patients suffering from this devastating liver disease, Patel said. Saroglitazar Mg has previously shown an 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. DRR SID