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EMA Unconvinced By Xiidra Dry Eye Data

Withdrawn Filing For Novartis’s Lifitegrast Was Found Wanting

 
• By Maureen Kenny

The data package used to secure the US approval of Novartis's dry eye drug Xiidra (lifitegrast) was not enough to convince European regulators and experts in the field of eye diseases that the treatment should be sold in the EU.

Eye_Dropper
A variety of approaches is used in treating dry eye syndrome • Source: Shutterstock

Novartis failed to demonstrate in its attempt to secure pan-EU marketing approval for Xiidra (lifitegrast) that the dry eye treatment worked sufficiently well in the indication the company was seeking, the European Medicines Agency has found. The data package that was used to support the EU application was the same as that which secured the product's approval in the US back in July 2016.

Novartis AG withdrew its marketing authorization application (MAA) for lifitegrast 50 mg/ml eye drops solution from the EMA review...

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