Novartis strikes out with dry eye med Xiidra in Europe

Novartis (NYSE:NVS) has withdrawn its marketing application in Europe seeking approval of Xiidra (lifitegrast) for the treatment of dry eye disease.

The advisory group CHMP was not on board citing a lack of data proving efficacy. In studies, “some effect” was observed in reducing eye dryness, but the improvement was not considered clinically significant. Since lifitegrast was targeted for patients with more severe disease for whom artificial tears were not sufficient to improve the condition, the agency had “concerns” about how these patients were to be selected, noting that studies compared Xiidra with vehicle (placebo) and had not used artificial tears in an optimal way. Also, there were no data on the effects of long-term treatment despite eye dryness being a chronic disease.

The setback has to be painful for the company since it paid $3.4B in upfront cash to Takeda a year ago for the product (the deal also included up to $1.9B in potential milestones).

The FDA approved Xiidra for the indication in July 2016.

https://seekingalpha.com/news/3586459-novartis-strikes-out-dry-eye-med-xiidra-in-europe