Zydus rises on regulator’s nod for drug to treat liver disease

Mumbai: Shares of Zydus Cadila rose by 3 per cent on the BSE as the drugmaker announced that it had received an approval from the drug controller to market its novel molecule Saroglitazar for the treatment of non-alcoholic fatty liver disease. The Ahmedabad-based company plans to launch the drug in India in the next three months, even as it is aiming for global filing in the coming quarters.


Shares of the company closed at Rs 263.55 on the bourse.


Saroglitazar, which is under research for three other indications besides diabetes, is the first novel molecule to have received an approval for fatty liver disease or non-cirrhotic non-alcoholic steatohepatitis (NASH).

“It is a global programme for us. This is our first milestone — we have become the first company in the world to have an approved therapy for NASH,” Sharvil Patel, managing director, Zydus Cadila, told ET.

In the US, the company has presented a phase-2 study for the molecule and is marching towards phase-3 studies.

“We not only want to have a global molecule but also have multiple indications for this drug,” said Patel.

NASH is a progressive disease of the liver, which starts with fat accumulation in the liver known as nonalcoholic fatty liver disease. This condition could progress to cirrhosis and liver failure. It is a large unmet medical need as there is currently no approved drug for the treatment of NASH anywhere in the world. The first-line treatment paradigm includes diet and change in lifestyle.

The prevalence of NASH in India is estimated to be nearly 25 per cent of the population. NASH ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease. Liver transplantation is the only option for managing advanced cirrhosis with liver failure.

For Zydus Cadila, this molecule marks a step forward in its global ambition of launching a new molecule. Across the world several companies such as Novartis, Gilead and Novo Nordisk have been working on a therapy for NASH. The market size for these drugs, which have yet to be approved, ranges between $35-40 billion, according to industry estimates.

Patel said that beyond oncology this is the second biggest therapy opportunity for pharma companies. Zydus Cadila hopes to approach the US Food and Drug Administration in the first quarter of next year once it is prepared with the phase-3 programme.