Zydus Cadila files NDA for Saroglitazar Magnesium

Drug firm Zydus Cadila on Thursday said it has filed New Drug Application (NDA) with the Drug Controller General of India (DCGI) for Saroglitazar Mg, used in treatment of liver disease.

"Zydus Cadila...has filed the NDA of Saroglitazar Mg in non-alcoholic Steatohepatitis (NASH) with the Drug Controller General of India (DCGI)," the drug firm said in a regulatory filing.

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 significant need for new therapies for patients with NASH, who have no treatment options as their liver disease progresses, other than opting for eventual liver transplants to survive," Zydus Group Chairman said Pankaj R Patel said.

Saroglitazar Mg has demonstrated beneficial effects in NASH animal models, the filing said adding that Saroglitazar Mg favourably affects all components of NASH including steatosis, ballooning, inflammation and fibrosis in NASH models.

"We are very pleased that our NDA filing has been accepted for review which we believe represents an important step towards providing an innovative treatment option for millions of patients suffering from this devastating liver disease," Patel said.

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.