Shire Announces Submission Of MAA For Lifitegrast - Quick Facts

(RTTNews) - Shire plc (SHPG, SHP.L) announced that the Marketing Authorization Application for lifitegrast for the treatment of dry eye disease in Europe, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure. The lifitegrast MAA was submitted via the Decentralized Procedure to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece.

In the U.S., FDA approved lifitegrast under the brand name Xiidra (lifitegrast ophthalmic solution) 5% for the treatment of signs and symptoms of dry eye disease in July 2016.