Shire files NDA at FDA for lifitegrast to treat dry eye disease
Shire plc announced that the company has submitted a New Drug Application (NDA) with the FDA for its investigational compound lifitegrast (SHP 606) for the treatment of signs and symptoms of dry eye disease in adults. Lifitegrast has potential to be the first treatment indicated to address both the signs and symptoms of dry eye disease, a chronic inflammatory condition which affects millions of people. The NDA submission is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These included one Phase II study, two Phase III efficacy and safety studies, and one long-term Phase III safety study.
Comment; Lifitegrast will be a competitor to long established Restasis from Allergan which claims patent protection until 2024 but is under generic challenge.
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