India has become the first to act on non-alcoholic fatty liver disease: Sharvil Patel

Rutam Vora Ahmedabad | Updated on February 26, 2021

Sharvil Patel, Managing Director, Zydus Cadila

Zydus Cadila MD explains how his company’s drug Saroglitazar Mg in significant in treating the disease

The Union Health Ministry has operationalised guidelines to integrate Non-Alcoholic Fatty Liver Disease (NAFLD) into the National Programme for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS), a step towards addressing India’s non-communicable diseases (NCDs). In an interview to BusinessLine, Zydus Cadila Managing Director Sharvil Patel explains the significance of treating this global unmet medical need. Zydus recently received regulatory approval on Saroglitazar Mg for NAFLD treatment. Excerpts:

How do you see the Centre's decision on integrating NAFLD into the larger programme?

This is a very timely step to identify the need for action on NAFLD. India has become the first country to do so and it will help in controlling the epidemic of NAFLD / Non Alcoholic SteatoHepatitis (NASH). This will bring in a sense of urgency in addressing the silent epidemic of NAFLD and NASH in India.

Why does NAFLD need specific attention?

NAFLD, though a non-communicable disease (NCD), is an independent predictor of future risk of cardiovascular disease, Type 2 diabetes and other metabolic syndromes like hypertension, abdominal obesity, dyslipidaemia, glucose intolerance. The operational guidelines help align existing NCD programme strategies to achieve the objectives of prevention and control of NAFLD. We see a greater integration and convergence in the approaches as the focus will be on prevention, early diagnosis and management of NAFLD with both lifestyle changes and medication.

How serious is India’s situation compared to other countries?

NAFLD is a condition where the liver has fat accumulation and could lead to NASH a progressive disease of the liver. This condition could progress to cirrhosis and liver failure. It is a large unmet medical need. There is currently no approved drug for the treatment of NASH anywhere in the world.

Over 20 years, the global burden of NASH has more than doubled from 40 lakh prevalent cases of compensated cirrhosis in 1990, to 94 lakh cases in 2017. This is a disease that is highly prevalent with 10-30 per cent of the global population being affected by it.

India’s NASH prevelance is estimated at 25 per cent of the population and ranks as a major cause of cirrhosis, hepatitis C and alcoholic liver disease.

In absence of a drug for NASH, what is the option for the patients?

Liver transplant is the only option for managing advanced cirrhosis with liver failure. Rising cases of obesity due to sedentary lifestyle is an equally alarming issue. About 3-15 per cent of the obese patients with NASH progress to cirrhosis and about 4-27 per cent of NASH with cirrhosis patients transform to HCC (Hepatocellular Carcinoma). An alarming rise in metabolic diseases, in the developing and developed world, is expected to result in NAFLD/NASH-HCC posing a serious health threat in future.

Zydus had been granted approval by DCGI for Saroglitazar Mg for NAFLD treatment. How will it address the medical need?

Saroglitazar Mg has been approved for the treatment of both NAFLD and NASH in India. It was launched in India in September 2013, for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. With its unique mechanism of action that enables it to regulate both insulin & lipid metabolism, we started exploring other treatment options for other unmet healthcare needs as well.

Interestingly, as NAFLD and NASH are also a part of the metabolic syndrome and linked to diabetes and impaired lipid levels, we did see some positive clinical outcomes in patients who were already on Saroglitazar and in addressing their symptoms of NAFLD and NASH.

Almost 1.5 million patients benefited from this drug and it was an indication that Saroglitazar Mg could provide hope and better quality of life for patients in India suffering from these chronic diseases.

What progress has Saroglitazar made globally?

On the global front, EVIDENCES IV, the phase-II clinical trial of Saroglitazar Mg in patients with NASH in the US met its primary and secondary endpoints, the results of which were presented at AASLD 2019. We have also initiated enrolment of patients across several clinical sites in the US and Mexico for an EVIDENCE VII Phase II clinical trial for evaluation of Saroglitazar in the treatment of NAFLD in women with polycystic ovary syndrome (PCOS). In January, 2021 the USFDA also granted an Orphan Drug Designation apart from the earlier Fast Track Designation to Saroglitazar Mg for the treatment of PBC.

What are your business-wise projections on Saroglitazar Mg?

Our focus over the last decade has been on innovations for unmet healthcare needs. I think Saroglitazar Mg and others in the pipeline at various stages of clinical research, are all about this. There would be a first mover advantage as this a novel drug. The more important thing is, there is now a treatment option at hand to prevent advancement of this disease and to have patients lead healthier lives.

The Indian government looks to more from curative to a preventive approach. Does your product fit that bill?

Preventive health interventions are very important as they help address the symptoms of a disease early on. Preventive tests not only help in timely action but can also reduce the disease burden for families. Lifestyle modification, including significant weight loss through hypocaloric diet and exercise, is considered as a first-line intervention for the treatment of NAFLD, as weight loss is associated with a reduction in liver fat, which provides potential for reversal of disease progression. Besides the focus on yoga and wellness sessions at the community level, the focus of ‘Eat Right India’ and ‘Fit India Movement’, can also address NAFLD in its initial stages.

Published on February 25, 2021

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