Shire's Xiidra Gets Advantageous Label Covering Signs, Symptoms Of Dry Eye Disease
By examining the "totality of the data" including a Phase II study, FDA approved drug for both measures of dry eye, despite mixed results in pivotal trials.
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A year after inking a multi-billion dollar deal to get hold of the Takeda eye drop, Novartis has given up on getting approval for Xiidra in Europe with the EMA unconvinced about the therapy's efficacy.
Shire got hold of the eyedrop product in 2013 through its acquisition of SARcode which cost $160m and despite struggling on the market, Novartis is paying $3.4bn upfront to buy Xiidra.
Market Snapshot: Shire is pushing Xiidra hard to take market share away from Allergan's well established Restasis, but the pending arrival of a generic Restasis throws a curveball into the whole category.