Lipaglyn (Saroglitazar) is a dual peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of hypertriglyceridemia in Type II diabetics.
The drug was discovered and developed by Zydus Cadila, a pharmaceutical company based in India.
Zydus Cadila submitted a new drug application (NDA) for Lipaglyn’s approval to the Drug Controller General of India (DCGI) in 2012. It received marketing approval for Lipaglyn from the DCGI for treating diabetic dyslipidemia in Type II diabetics in June 2013.
Hypertriglyceridemia in type II diabetics
Hypertriglyceridemia, also known as diabetic dyslipidemia, is a condition in which a person with diabetes has very high blood lipid levels or triglycerides.
The elevated level of triglycerides is one of the major risk factors associated with cardiovascular diseases (CVD).
India is estimated to have approximately 65 million people with diabetes, with more than 80% of them suffering from diabetic dyslipidemia. An estimated 85% of diabetics in the world are suffering from diabetic dyslipidemia.
It is also found that about 30% of deaths in the world are caused by CVD, and diabetes is one of the major causes associated with CVD.
Lipaglyn’s (saroglitazar) mechanism of action
Lipaglyn contains two main classes of PPAR agonists, which include PPARa (alpha) and PPAR? (gamma). The drug has both lipid and glucose lowering effects in a single molecule. It lowers the high blood triglycerides as well as blood sugar, and improves the insulin resistance. The drug is available in tablet form of 4mg dose for oral administration.
Clinical trials on Zydus’s Lipaglyn (saroglitazar)
The approval for Lipaglyn was based on the results obtained from clinical studies, which were conducted for more than eight years. The studies evaluated the efficacy, safety, pharmacokinetics and pharmacodynamics of the drug.
Phase I clinical trials on Lipaglyn were conducted in 2005, and Phase II studies were completed in 2006. The Phase III clinical trials were conducted between 2008 and 2011.
The first Phase III clinical trials on Lipaglyn compared Lipaglyn 4mg dose with pioglitazone, a similar drug developed by Takeda.
The results of the study demonstrated that patients who were administered with Lipaglyn 4mg dose showed reduction in LDL cholesterol and triglycerides, and increase in HDL cholesterol. The study also showed that Lipaglyn-administered patients showed a reduction in fasting plasma glucose and glycosylated haemoglobin.
The second Phase III clinical trials on Lipaglyn were conducted to evaluate the diabetic dyslipidemic patients insufficiently controlled with statin therapy.
The second Phase III study results showed that patients treated with Lipaglyn showed pronounced beneficial effect on both the lipid and glycaemic parameters.
Lipaglyn was well tolerated and the safety profile of the drug was shown to be better than its comparator drugs in both trials. It was also found that the drug had a non-renal route of elimination and didn’t show adverse events such as oedema, weight gain, myopathies, or derangement of liver and/or kidney functions, thus making it safe and effacious.
Marketing commentary for India’s Zydus Cadila
Zydus Cadila, which is part of Zydus Group, is a leading international pharmaceutical company with its headquarters located in Ahmadabad, India. The company discovers, develops, produces and markets a wide range of healthcare therapies.
Zydus Cadila plans to launch Lipaglyn across the Indian market in the third quarter of 2013. The company spent about $250m for the development of Lipaglyn.
It plans to spend another $150m to $200m to launch the drug in overseas markets in the next three to five years.
Lipaglyn is expected to be a blockbuster drug in the coming years. The drug is expected to have $30bn market globally. The drug will face competition from Takeda’s Actos (pioglitazone).