Cadila Healthcare on December 5 said it has filed the New Drug Application (NDA) of Saroglitazar Mg with the Drug Controller General of India (DCGI).
"Saroglitazar Magnesium was launched in India in September 2013, for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with type-2 diabetes not controlled by statins," the company said in an exchange filing.
If the latest NDA is approved, Saroglitazar Mg could become the first medicine indicated for the treatment of Non-alcoholic Steatohepatitis (NASH).
NASH is a progressive disease of the liver and a significant unmet medical need. It involves liver inflammation and damage caused by a build-up of fat in the liver.
Currently, there is no treatment available for NASH.
Starting with fat accumulation in liver, this condition can progress to cirrhosis and liver failure. It is one of the major causes of cirrhosis, coming only after hepatitis C and alcoholic liver disease. Liver transplantation is the only recourse available to manage advanced cirrhosis with liver failure.
"There is a significant need for new therapies for patients with NASH, who have no treatment options as their liver disease progresses, other than opting for eventual liver transplants to survive," said Pankaj R Patel, Chairman, Zydus group.
"We are very pleased that our NDA filing has been accepted for review which we believe represents an important step towards providing an innovative treatment option for millions of patients suffering from this devastating liver disease," he added.
Cadila said that Saroglitazar Mg has demonstrated beneficial effects in NASH animal models.
Saroglitazar Mg has previously demonstrated improvement in both liver enzymes along with favourable effects on lipid and glycemic indices in patients with non-alcoholic fatty liver disease in Phase II clinical trials, the company said.
In clinical trials, Cadila said the drug achieved positive results in a biopsy-driven trial of Saroglitazar 4 mg versus Placebo in patients with Non-Alcoholic Steatohepatitis.
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