Shire provides update on next steps for lifitegrast in light of FDA CRL
Company plans to refile lifitegrast submission in the first quarter of 2016.
Shire announced that the FDA 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. Shire has recently completed a Phase III study of lifitegrast, OPUS-3, that, if positive, will be the basis of Shire’s response to the CRL.
“We were disappointed, but will soon have data from the Phase III study, OPUS 3,” said Flemming Ornskov, CEO, Shire. “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. We are committed to working with FDA to expeditiously provide the evidence required to deliver a new prescription treatment option for the 29 million adults in the US living with the symptoms of this chronic and progressive disease. This is an area of unmet medical need for which there has been no new FDA-approved treatment in over a decade.”
The FDA also requested more information related to product quality, which Shire is confident it can address in the CRL response.
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