Zydus Cadila gains Indian approval for diabetes therapy Lipaglyn

Zydus Cadila announced Wednesday approval from the Drug Controller General of India for Lipaglyn (saroglitazar) as a treatment for hypertriglyceridaemia in patients with type II diabetes not controlled by statins alone. Zydus Cadila said that the drug is the first from the glitazar class to be approved anywhere in the world and is the first new chemical entity developed by an Indian company to reach the market.

Managing director Pankaj Patel noted that the drugmaker took about eight years to develop Lipaglyn at a cost of $250 million and the compound has been studied in more than 1000 patients in India. Results from a Phase III programme comparing Lipaglyn to pioglitazone showed that the 4 milligram dose of Zydus Cadila's agent led to a reduction of triglycerides and LDL cholesterol, and an increase in HDL cholesterol. Lipaglyn also demonstrated a reduction in fasting plasma glucose and glycosylated haemoglobin.

"Lipaglyn provides patients suffering from diabetic dyslipidaemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycaemic control," Patel commented. The executive indicated that Zydus Cadila plans to spend $150 million to $200 million on launching the drug outside India. "We expect this to be a blockbuster drug," Patel remarked, adding that initially the company is targeting sales of 1 billion rupees ($17.6 million) in India over three years.

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