Novartis withdraws Xiidra marketing authorization application

Novartis Europharm has withdrawn its marketing authorization application for its dry eye product Xiidra, the European Medicines Agency announced on its website.
In the withdrawal letter to the EMA, Novartis gave the reason for the withdrawal as an inability to resolve the agency’s major objections within the available time frame.
At the time of the withdrawal, the EMA’s opinion was that effectiveness of Xiidra (lifitegrast) 50 mg/mL eye drops was not proven and therefore the benefits did not outweigh the risks.
The application was for treatment of moderate to severe (Read more...)

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