Zydus Cadila said Mexico’s drug regulator granted marketing approval to market its diabetes drug Lipaglyn in Mexico.
The drug can be used to bring down cholesterol levels in patients even when conventional therapies like statins fail.
“This approval of Saroglitazar in Mexico is a major milestone for the company,” said Chairman Pankaj Patel.
Lipaglyn was first launched in India during September 2013. Over the last several years, more than 500,000 patients have been treated with LipaglynTM in India, and data has been presented at several scientific and medical conferences, it claimed.
“Saroglitazar is an important Scientific and medical breakthrough in our effort to develop medicines for patients suffering from hypertriglyceridemia and diabetic dyslipidemia.”
The drug Saroglitazar Magnesium can be used for the treatment of Dyslipidemia — or the abnormal rise in lipid levels — in patients with Type 2 diabetes mellitus, the company said.
It can also be used to control tiglyceride levels in patients with diabetes mellitus type 2 not controlled by statins.
Zydus is currently evaluating Saroglitazar in several clinical trials for treating liver conditions like NASH and Primary Biliary Cholangitis (PBC).
“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),” it said.
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.
Zydus Cadila develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines.
The group employs over 21,000 people worldwide, including 1200 scientists engaged in R & D, and is dedicated to creating healthier communities globally.