Shire plc (LSE: SHP, NASDAQ: SHPG) today 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 and, if approved, 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 October 25, 2015, based on the Prescription Drug User Fee Act V action date.
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
“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. We look forward to working closely with the FDA throughout the review process.”
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.”
Lifitegrast is a novel small-molecule integrin inhibitor. It binds to the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand ICAM-1 (intercellular adhesion molecule-1). ICAM-1 is over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction contributes to the formation of immunological synapses resulting in T-cell activation and migration to target tissues.
As defined by the 2007 Dry Eye WorkShop (“DEWS”), sponsored by the Tear Film & Ocular Surface Society (TFOS), dry eye 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 accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. Dry eye, an often chronic and progressive ocular disease, is one of the most common complaints to eye care professionals, and represents a significant unmet need.1,2
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
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Statements included in this announcement that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
and other risks and uncertainties detailed from time to time in Shire’s filings with the US Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
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1 Schaumberg DA, Sullivan DA, Buring JE et al. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26.
2 Schaumberg DA, Dana R, Buring JE et al. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8.