Xiidra

Generic name: lifitegrast
Treatment for: Dry Eye Disease

Update: Xiidra (lifitegrast) Now FDA Approved - July 11, 2016

Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults

Lexington, Mass. – March 2, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the company has submitted a New Drug Application (NDA) with the U. S. Food and Drug Administration for its investigational compound lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.

“Lifitegrast has potential to be the first treatment indicated to address both the signs and symptoms of dry eye disease, a chronic inflammatory condition which affects millions of people,” said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. “Our FDA submission is an important milestone that underscores Shire’s commitment to developing innovative specialty medicines in areas of high unmet medical need.”

The NDA submission is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These included one Phase 2 study, two Phase 3 efficacy and safety studies, and one long-term Phase 3 safety study.

About Lifitegrast

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.

About Dry Eye Disease

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 medical need^{1, 2}.

About Shire

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.

THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

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:

Shire’s products may not be a commercial success;

product sales from ADDERALL XR and INTUNIV are subject to generic competition;

the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for Shire's products may affect future revenues, financial condition and results of operations;

Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of the Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of the Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;

the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;

Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;

the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;

investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;

adverse outcomes in legal matters and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of operations;

Shire faces intense competition for highly qualified personnel from other companies and organizations. Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect Shire’s ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;

failure to achieve Shire’s strategic objectives with respect to the acquisition of NPS Pharmaceuticals, Inc. may adversely affect Shire’s financial condition and results of operations;

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.

References

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.
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

Posted: March 2015

FDA Approves Xiidra (lifitegrast ophthalmic solution) for Dry Eye Disease - July 12, 2016
U.S. FDA Acknowledges Receipt of Resubmission of Shire’s NDA for Lifitegrast for Dry Eye Disease in Adults - February 4, 2016
Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA - January 25, 2016
Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial - October 16, 2015
U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye Disease in Adults - April 9, 2015
Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults - May 16, 2014

Xiidra (lifitegrast) FDA Approval History

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