Following the recent news that The Drug Controller General of India (DCGI) has approved Zydus Cadila’s new drug application (NDA) for Lipaglyn (saroglitazar) for treatment of Non-Cirrhotic, Non-Alcoholic Steatohepatitis (NASH) in India;

Nag Madhavi, Healthcare Analyst at GlobalData, a leading data and analytics company, offers her view:

“Lipaglyn, which is a novel first in class molecule with dual peroxisome proliferator-activated receptor (PPAR) agonist mechanism, will help Zydus Cadila to cater to the high unmet need in the NASH market.

“According to GlobalData’s Pharmaceutical Intelligence Center, currently, the number of prevalent cases of NASH in India is 55.8 million and it is expected to grow at an annual growth rate of 1.2%. The increasing prevalence of the disease is highly linked to lifestyle factors along with conditions such as obesity and type 2 diabetes mellitus. NASH is a lucrative market for pharmaceutical companies, as the patient population is high and with no approved therapies. Lipaglyn is approved in India for the treatment of diabetic dyslipidemia, hypertriglyceridemia and type 2 diabetes, where it caters to more than one million patients.

“Globally there are no approved drugs for NASH and the disease management includes various strategies such as lifestyle modifications (like exercises, weight loss, diet modification) and specific treatment of comorbidities.

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“Hence, the approval of Lipaglyn provides a ray of hope for the physicians. Lipaglyn is currently in Phase II in the US and according to GlobalData’s assumptions, the expected approval is in H2 2027. Further in clinical development is Intercept Pharmaceuticals’ obeticholic acid, which is expected to be approved in the US in 2020.

“This event marks a significant milestone for Indian pharma companies as they have not been as strong in new chemical entity development as their counterparts in the US and EU, and being the first among global companies to secure an approval for a disease where no drugs are yet approved across the world would be a defining moment for the Indian pharma industry. Furthermore, this drug could leverage a significant market share based on its first mover advantage, coupled with a large patient base and good domestic reach of the company.”