FDA grants Priority Review designation to Lifitegrast for the treatment of dry eye disease
Posted: 13 April 2015 |
Shire has announced that the FDA has accepted for filing the New Drug Application (NDA) for Lifitegrast and granted a Priority Review designation…
Shire has announced that the United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Lifitegrast and granted a Priority Review designation.
Lifitegrast is an investigational treatment for dry eye disease in adults. Dry eye disease is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is one of the most common complaints to eye care professionals, and represents a significant unmet need. 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 provide a decision on 25 October 2015.
The FDA grants Priority Review designation to drugs that have the potential to provide significant improvements in the safety or effectiveness for the treatment, diagnosis or prevention of a serious disease. Drugs with Priority Review designation have an accelerated review target of eight months, instead of the standard of 12 months.
Lifitegrast could be the first treatment to address both the signs and symptoms of dry eye disease
“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, Ph.D., Head of Research and Development, Shire. “Our commitment to moving Lifitegrast forward reflects our intent to grow in the ophthalmics therapeutic category in areas of unmet patient need.”
The NDA filing is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These include one Phase 2 study, two Phase 3 efficacy and safety studies, and one long-term Phase 3 safety study.
“The symptoms of dry eye are one of the most common complaints from patients, yet there remains a tremendous unmet need,” said Stephen C. Pflugfelder, M.D., Professor of Ophthalmology at Baylor College of Medicine, Houston, Texas. “It’s encouraging to see Shire moving the program for lifitegrast forward.”
For more information about Shire, please visit www.shire.com.
