Novel Indian discovered dyslipidemia drug approved in Mexico

Indian drugmaker Zydus Healthcare today announced that the Mexico regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval to commercialize Lipaglyn (saroglitazar magnesium) in Mexico for the treatment of dyslipidemia in patients with diabetes mellitus type 2 and hypertriglyceridemia in patients with diabetes mellitus type 2 not controlled by statins.

Granted Indian approval in 2013 and launch that year, Lipaglyn became the first glitazar to be approved anywhere in the world and the first New Chemical Entity (NCE) discovered and developed indigenously by an Indian pharma company.

Elevated triglycerides and insulin resistance are two key components of the metabolic syndrome, which medical science believes are responsible for diseases like hypertriglyceridemia, diabetic dyslipidemia or non-alcoholic steatohepatitis disease (NASH). Increased triglyceride accumulation in the liver can also lead to inflammation, fibrosis, cirrhosis and liver failure, a serious medical condition known as NAFLD or NASH.