European Medicines Agency grants Orphan Drug Designation to Zydus Cadila’s Saroglitazar Mg

By: |
July 21, 2021 2:22 PM

Orphan Drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare, life-threatening, or chronically debilitating conditions affecting no more than 5 people in 10,000 people.

zyadus cadila"European Medicines Agency (EMA) has granted 'Orphan Drug Designation' (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC)," Zydus Cadila said in a statement. (Representational image)

Drug firm Zydus Cadila on Wednesday said the European Medicines Agency has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg, used in the treatment of liver disease. Orphan Drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare, life-threatening, or chronically debilitating conditions affecting no more than 5 people in 10,000 people.

It provides companies with a range of incentives, including assistance with trial protocols, reduced regulatory fees, differentiated evaluation procedures for Health Technology Assessments in certain countries, access to a centralized marketing authorization procedure valid in all EU Member States, and a 10-year period of market exclusivity, if the treatment eventually is approved.

“European Medicines Agency (EMA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar Mg for the treatment of patients with Primary Biliary Cholangitis (PBC),” Zydus Cadila said in a statement. PBC is a liver disease, caused due to progressive destruction of the bile ducts in the liver which leads to reduction of bile flow.

Earlier this year, the US’s health regulator USFDA had granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to Saroglitazar Mg for PBC.

Zydus Cadila said the global market for PBC treatment is expected to grow at a Compound annual growth rate (CAGR) of 36.3 per cent from 2018 2026, and is expected to reach USD 10.8 billion by 2026, as per Coherent market insights. Pankaj R Patel, Chairman, Zydus Group said Primary Biliary Cholangitis is a serious health condition and the company is committed in its clinical development efforts to improve the quality of life of patients suffering from PBC with a safe and efficacious treatment.

Get live Stock Prices from BSE, NSE, US Market and latest NAV, portfolio of Mutual Funds, Check out latest IPO News, Best Performing IPOs, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

Financial Express is now on Telegram. Click here to join our channel and stay updated with the latest Biz news and updates.

Next Stories
120,728 fresh COVID-19 cases in Kerala, 56 deaths
2Goa misses July 31 deadline to give first COVID-19 vaccine dose to all
3Covid-19 third wave threat: As 46 districts report over 10% positivity rate, a look at the 10 critical states in India