Approval to commercialize Lipaglyn™ (Saroglitazar Magnesium) in Mexico for treatment of:
- Dyslipidemia in patients with diabetes mellitus type 2.
- Hypertriglyceridemia in patients with diabetes mellitus type 2 not controlled by statins
Zydus 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.
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. Additionally, Zydus is currently evaluating Saroglitazar in several clinical trials for treating liver conditions like NASH and Primary Biliary Cholangitis (PBC).
“Saroglitazar is an important scientific and medical breakthrough in our effort to develop medicines for patients suffering from hypertriglyceridemia and diabetic dyslipidemia,” said Pankaj Patel, Chairman, Zydus Group, and added, “This approval of Saroglitazar in Mexico is a major milestone for the company.”
Saroglitazar (Lipaglyn™) is a novel PPARα/γ agonist having predominant PPAR alpha activity. The recommended dose of Lipaglyn™ is 4 mg once-a-day. Lipaglyn™ is a prescription drug and should be taken under guidance of a registered medical practitioner. Lipaglyn™ was first launched in India during September 2013. Over the last several years, more than 500,000 patients have been treated with Lipaglyn™ in India, and data has been presented at several scientific and medical conferences.