FDA declines approval of Shire's dry eye drug Lifitegrast
Ireland-headquartered drugmaker Shire (LSE: SHP) revealed on Friday that the US Food and Drug Administration has requested an additional clinical study as part of a complete response letter (CRL) to the company’s new drug application for Lifitegrast for the signs and symptoms of dry eye disease in adults.
The news comes just over a week before the FDA Prescription Drug User Fee Act V action date of October 25 for this dry eye disease, which analysts have forecast has a $1 billion-a-year-plus sales potential.
New data submission to FDA expected in 1st-qtr 2016
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