The approval, which authorizes the sale of the product in all 28 member states of the European Union, follows the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Ravicti is a designated orphan medicinal product featuring a new active substance. It has a period of 10 years of regulatory data/market protection with a potential extension to 11 years.
The approval also includes a period of 10 years of orphan market exclusivity concurrently applied to each of the approved six sub-types of the UCDs.
UCDs are metabolic diseases that affect a particular enzyme or transporter of the urea cycle, resulting in increased levels of ammonia in the blood stream.
Horizon Pharma chairman, president and CEO Timothy Walbert said: "The approval of Ravicti in the European Union and the European Economic Area represents a significant milestone for Horizon Pharma as we expand our business globally.
"With this approval, we will now focus on developing country-by-country plans to make Ravicti available to people with urea cycle disorders throughout Europe."
The US Food and Drug Administration approved Ravicti in February 2013 for chronic management of UCDs in adult and pediatric patients more than or equal to 2 years of age.