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

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

By, Admin 12 March 2021

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. 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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!