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In a major breakthrough in the treatment of non-alcoholic steatohepatitis (NASH), healthcare major Zydus Cadila has announced the filing of a new drug application (NDA) for Saroglitazar Magnesium with the Drug Controller General of India (DCGI).
Subject to approvals, the drug could become the first globally to be indicated for the treatment NASH. Currently, there is no treatment available for this progressive liver disease, said Zydus in a statement on Thursday.
“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 Zydus Group Chairman Pankaj Patel in the statement.
Progressive disease
Starting with fat accumulation in the liver, this condition can progress to cirrhosis and liver failure. NASH ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease. Liver transplant is the only option for managing advanced cirrhosis with liver failure.
Patel expressed pleasure over the NDA filing, which 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”.
Saroglitazar Mg 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 drug, which has demonstrated beneficial effects in NASH animal models, favourably affects all components of the disease including steatosis, ballooning, inflammation and fibrosis, said the release.
Trial successes
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. Zydus had also achieved positive results in EVIDENCES II phase 3 biopsy-driven trial of Saroglitazar 4 mg versus placebo in patients with NASH, said the release.
The primary endpoint evaluated the histological improvement of NASH using liver biopsy at the end of 52 weeks. Separately, the results of the EVIDENCES IV trial of Saroglitazar Mg in patients with NASH were presented as a Late Breaker at The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases.
Cadila Healthcare shares traded on Thursday on the NSE at ₹258.30, down about 2 per cent from its previous close.
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