Saroglitazar Mg, approved by the Drug Controller General of India (DCGI), becomes the first medicine for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD).
Cadila Healthcare announced that DCGI has approved its New Drug Application (NDA) for Saroglitazar Mg for the treatment of NAFLD in India.NAFLD is a progressive disease of the liver, which starts with fat accumulation in the liver in patients who do not consume alcohol or take it in insignificant amounts, but have risk factors such as overweight or obesity, diabetes mellitus (high blood sugar), hypertension (high blood pressure) or dyslipidemia (abnormal blood lipids). This NAFLD condition could progress to NASH, cirrhosis and liver failure. It is a large unmet medical need as there is currently no approved drug for the treatment of NAFLD and NASH anywhere in the world.
The prevalence of NAFLD in India is estimated to be nearly 25-30% of the general population. This approval for NAFLD along with either of the comorbidities (obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome) provides the physicians with a viable treatment option. With a once daily, 4mg dose regimen, Saroglitazar Mg will enable better compliance, reduces the pill burden and offers the patient more convenience, the company said in a statement during market hours today, 30 December 2020.
Shares of Cadila Healthcare rose 0.04% to Rs 479.20.
The company's consolidated net profit soared 411% to Rs 423.60 crore on 16% jump in net sales to Rs 3,762.30 crore in Q2 September 2020 over Q2 September 2019.
Cadila Healthcare is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.
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