OREANDA-NEWS. February 08, 2016. Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2016.

“The resubmission is an important milestone for Shire and our commitment to providing a new treatment option for the 29 million adults in the U.S. living with the symptoms of dry eye disease,” said Philip J. Vickers, Ph.D., Head of Research & Development, Shire. “We believe that this resubmission package, which includes our positive OPUS-3 data, as well as information about product quality, will address the requests from the FDA. Ophthalmics is a key focus area for Shire, and we’re pleased to see our lead candidate continue to advance.”

The new drug application for lifitegrast now includes data from five clinical trials, including one Phase 2 study, three Phase 3 safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3) and one long-term (one year) Phase 3 safety study (SONATA). This is the largest clinical trial program for an investigational-stage compound in dry eye disease with over 2,500 patients.

Shire originally submitted the NDA for lifitegrast to the FDA in February 2015. In April 2015, the FDA granted Priority Review designation to lifitegrast, which accelerated the review target to eight months instead of the standard 12 months.

About Lifitegrast
Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 is over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction contributes to formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies have demonstrated that lifitegrast inhibits T-cell adhesion to ICAM-1 expressing cells and inhibits secretion of key inflammatory cytokines (IFN?, TNF?, IL-2) as well as inhibiting other proinflammatory cytokines: IL-1?, IL-1?, IL-2, IL-4, IL-5, and IL-13, all of which are known to be associated with dry eye disease.

About OPUS-3
OPUS-3, a Phase 3 study that evaluated the efficacy and safety of lifitegrast 5% versus placebo, met the primary endpoint of significantly improving patient-reported symptoms of dry eye disease from baseline to day 84 (p=0.0007), and met key secondary endpoints of symptom improvement from baseline to days 14 and 42 (p<0.0001 for both endpoints).

About Dry Eye Disease
Dry eye is a multifactorial disease of the tears and ocular surface. It is diagnosed by an eye care professional based on patient reported symptoms, such as eye dryness, overall eye discomfort, stinging, burning, a gritty feeling or fluctuating blurry vision, as well as signs, which can be measured by an eye care professional to determine the presence of dry eye disease (e.g., Schirmer test, corneal fluorescein staining, conjunctival lissamine green staining, and tear break-up time). Age and gender are recognized as traditional risk factors of dry eye disease while modern risk factors include prolonged screen time, contact lens wear and cataract or refractive surgery. Dry eye is an often chronic ocular disease associated with inflammation that may eventually lead to damage to the surface of the eye. Dry eye may be progressive and is a common complaint to eye care professionals.

Shire’s Commitment to Ophthalmics
In May 2014, Shire established its Ophthalmics Business Unit, solidifying its commitment to growing in this therapeutic area. Shire’s multi-faceted approach to discovery, development, and delivery in both rare diseases and specialty conditions includes our efforts to address unmet needs in eye care.

Shire’s ophthalmics business has been driven by a combination of strategic acquisitions and organic growth. Committed to growing its reputation as a leading biotech company, Shire is focused on continuing to expand its ophthalmics portfolio to include treatment options for rare diseases and those for anterior and posterior segment eye conditions. In just over two years, acquisitions include Foresight Biotherapeutics, SARcode Bioscience, Premacure AB, and BIKAM Pharmaceuticals, which have helped bolster Shire’s early-, mid- and late-stage ophthalmics pipeline. The Company currently has an ophthalmics pipeline of investigational candidates in dry eye disease, infectious conjunctivitis, retinopathy of prematurity, autosomal dominant retinitis pigmentosa, and glaucoma.

Download the PDF for the full release

For further information please contact:

NOTES TO EDITORS

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 we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.

For more information, please visit www.shire.com. Follow Shire on Social Media: @Shireplc, LinkedIn and YouTube.