Saroglitazar Mg is intended to treat non-alcoholic fatty liver disease and non-alcoholic steato hepatitis. Credit: Explode / Shutterstock.com.

Lupin and Zydus Lifesciences have signed a licensing and supply agreement for co-marketing Saroglitazar Mg to treat non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) in India.

Saroglitazar Mg, taken once daily at a 4mg dose, enhances patient compliance and lowers the number of pills required.

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In 2013, the drug was introduced in the country to treat diabetic dyslipidemia and hypertriglyceridemia in patients with type 2 diabetes (T2D) not controlled by statins alone.

In January 2020, Saroglitazar Mg received approval to treat patients with T2D mellitus. In March of the same year, it received approval to treat NASH.

Lupin will own semi-exclusive rights for co-marketing the drug in India under the LINVAS brand name.

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Zydus introduced the drug with the brand names Bilypsa and Lipaglyn and will continue their marketing.

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Based on the achievement of pre-defined milestones, Zydus will receive upfront licensing fees and milestone payments from Lupin.

Lupin managing director Nilesh Gupta stated: “We are excited to partner with Zydus to market Saroglitazar Mg for the treatment of NAFLD/NASH.

“This partnership re-affirms our commitment to grow and expand our offerings to meet unmet needs of patients in India.

“This partnership will further enhance our gastroenterology portfolio, offering better access to healthcare options to our patients and medical professionals.”

NAFLD is not limited to obese individuals or those with diabetes mellitus in India. It has also been observed that NAFLD can develop in non-obese individuals, and is referred to as “lean” NAFLD.