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Shire applies for marketing authorization in Europe for lifitegrast

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A marketing authorization application in the U.K. for lifitegrast for the treatment of dry eye disease has been validated, according to a Shire press release.

If approved, lifitegrast would be the first LFA-1 antagonist to address signs and symptoms of dry eye disease in adults in Europe, the release said.

“This submission is another important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a person’s vision-related quality of life, affecting daily activities such as reading and using computers,” Shire’s head of clinical development Howard Mayer, MD, said in the release.

The MAA was submitted through the Decentralized Procedure to Denmark, Norway, Sweden, Finland, the U.K., Germany, the Netherlands, France, Italy Portugal, Spain and Greece, with the U.K. being the reference member state.

 In the U.S., Xiidra (lifitegrast ophthalmic solution 5%) was FDA approved in July 2016 for treating the signs and symptoms of dry eye disease in adults.