Pharmaceutical company Zydus revealed on Friday the receipt of marketing approval for the commercialisation of 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.
This marketing approval has been awarded by Mexico regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk).
According to 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.
The company said the elevated triglycerides and insulin resistance are two key components of the metabolic syndrome responsible for hypertriglyceridemia, diabetic dyslipidemia or Non-Alcoholic Steatohepatitis disease (NASH). The increased triglyceride in the liver can lead to inflammation, fibrosis, cirrhosis and liver failure.
Concurrently, the company is currently evaluating Saroglitazar in several clinical trials for treating liver conditions like NASH and Primary Biliary Cholangitis (PBC).
Since September 2013, more than 500,000 patients have been treated with Lipaglyn in India and data has been presented at several scientific and medical conferences.
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