Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. This follows the grant of 'Fast Track Designation' by the USFDA to Saroglitazar Mg for PBC in December 2020.
Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist.
PBC is a liver disease, caused due to progressive destruction of the bile ducts in the liver which leads to reduction of bile flow — a condition referred to as cholestasis. The global market for PBC treatment is expected to grow at a CAGR of 36.3% from 2018 — 2026 and is expected to reach $10.8 billion by 2026 as per Coherent market insights.
Cadila Healthcare is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.
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.
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