Novartis yanks application from the EMA after regulators say researchers never proved efficacy of their $3.4B dry eye drug
Novartis is throwing in the towel on its campaign to get their dry eye disease drug Xiidra (lifitegrast) approved in Europe after regulators concluded that the drug fell short of the continental gold standard on drug approvals.
The EMA put out word that the Basel-based Novartis never proved the drug was actually effective at treating dry eye disease and that researchers had avoided using the standard approach — artificial tears — “in an optimal way.” The EMA concluded the drug didn’t pass the efficacy/safety standard in place, though the FDA green-lighted the drug 4 years ago. And Novartis concluded that there was no timely way to satisfy their concerns about a drug now sold in the US for a list price of around $6,600 a year.
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