Novartis Pulls EU Marketing Application For Xiidra
End Of Road For EU Marketing Plans For Dry Eye Drug?
Novartis recognized it would not be able to answer objections relating to its EU marketing application for the dry eye drug, Xiidra (lifitegrast), and so it has withdrawn the application. The company last year paid upwards of $3bn for the drug, which is already marketed in the US and other markets.
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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.
EU approval is likely for the eight medicines that got the thumbs up this week from the European Medicines Agency's drug evaluation committee, the CHMP. The panel held fire on one product it had been considering and also issued its first rejection of 2020.
A number of companies with marketing applications at the later stages of the EU review process are seeking extra time to address remaining concerns the European Medicines Agency’s drug evaluation committee, the CHMP, has about their filings.