Shire plans NDA filing with FDA for Lifitegrast in 1st-qtr 2015

18 May 2014

Following a May 15, 2014, meeting with the US Food and Drug Administration, Ireland-headquartered drugmaker Shire (LSE: SHP) says it intends to submit a New Drug Application for Lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in the first-quarter 2015.

In parallel to preparing for the NDA submission, and completing chemistry and manufacturing work, Shire will be assessing the need for gathering additional clinical data in support of the USA and potential international regulatory submissions.

Shire acquired rights to Lifitegrast, a small-molecule integrin antagonist, along with its $160 million upfront purchase of Australian firm SARcode Bioscience last year (The Pharma Letter March 26, 2013). The same year, Shire also acquired two further ophthalmic businesses: Sweden’s Premacure and USA-based Lotus Tissue Repair.

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