US Grants Priority Review for Shire’s Lifitegrast Dry Eye Treatment
The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Shire for its lifitegrast dry eye treatment for adults and has designated it as a Priority Review. If approved, lifitegrast has the potential to be the first treatment indicated to address both signs and symptoms of the disease.
The FDA is expected to give a decision on 25 October 2015. Priority Review designation, which is granted to drugs with the potential to significantly improve the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease, have an accelerated review target of eight months, instead of the standard 12 months.
"Our NDA filing for lifitegrast represents an important regulatory milestone, exemplifying Shire's ability to forge new paths in therapeutic areas aligned with our focus in rare and specialty conditions," said Philip J Vickers, Shire's head of research and development. He added: "Our commitment to moving lifitegrast forward reflects our intent to grow in the ophthalmics therapeutic category in areas of unmet patient need."
Dry eye is a progressive and often chronic disease and one of the most common complaints for professionals treating ocular conditions.
