Impact of Novartis' Xiidra MAA withdrawal on Takeda

In an announcement on Friday by the European Medicines Agency, it was revealed that Swiss pharma giant Novartis (NOVN: VX) has voluntarily withdrawn its Marketing Authorization Application (MAA) for Xiidra (lifitegrast ophthalmic solution), which was intended for the treatment of dry eye disease.

Based on the review of the data, including consultations with experts in the field of eye diseases and the company’s response to the EMA’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Xiidra could not have been authorized for the treatment of dry eye disease in adults for whom treatment with artificial tears has not been sufficient to improve the condition. Therefore, at the time of the withdrawal, the Agency’s opinion was that, because effectiveness was not proven, the benefits of Xiidra did not outweigh its risks.

Global rights to the drug were acquired by Novartis from Japan’s Takeda Pharmaceutical (TYO: 4502) in May 2019, under a deal that included a $3.4 billion upfront payment with potential milestone payments of up to $1.9 billion, as part of planned divestments following the $62 billion acquisition of rare diseases firm Shire, which originated Xiidra. 

Xiidra is the first and only prescription treatment approved by the US Food and Drug Administration for both signs and symptoms of dry eye disease, with a mechanism of action that targets inflammation. Ahead of the Novartis acquisition, Xiidra – which was approved in the USA in 2016 - had achieved $400 million sales and has been forecast as a $1.2 billion product at peak by Global Data.