19th Oct 2015 06:13
LONDON (Alliance News) - Irish pharmaceutical group Shire PLC on Monday said the US Food and Drug Administration has requested an additional clinical study be undertaken as part of its complete response letter to the new drug application made for Shire's lifitegrast drug for treating signs and symptoms of dry eye disease.
The FDA also requested more information on the product quality, Shire said.
The company said it has recently completed a phase 3 study on lifitegrast which, if positive, will form the basis of its response to the US regulator's letter.
"We were disappointed, but will soon have data from the Phase 3 study, OPUS 3," said Flemming Ornskov, Shire's chief executive.
"OPUS-3 has now been completed, and top-line data are expected before the end of the year. If the study is positive, we plan to refile our liftegrast submission in the first quarter of 2016, and will remain on track for the planned lifitegrast launch next year," he added.
By Sam Unsted; [email protected]; @SamUAtAlliance
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