Shire announces
submission of lifitegrast Marketing Authorization Application for
treatment of dry eye disease in Europe
Lifitegrast, if
approved, would be the first and only new class treatment to
address the signs and symptoms of dry eye disease in adults in Europe
Zug, Switzerland
- 15 August - Shire plc (LSE: SHP, NASDAQ: SHPG) announces that
the Marketing Authorization Application (MAA) for lifitegrast,
submitted on 07 August 2017, has been validated by the UK as the
Reference Member State involved in the Decentralized Procedure
(DCP). If approved, lifitegrast would be the first and only
treatment in a new class of drugs
(LFA-1 antagonist) to address the signs and symptoms of dry eye
disease in adults in Europe. The disease is most commonly
associated with eye dryness and overall eye discomfort, as well as
stinging, burning, and fluctuating blurry vision.[1] Dry
eye disease may significantly affect quality of life and may impact
activities such as reading and using computers.[2] It is
one of the most common conditions seen by ophthalmologists and eye
care practitioners worldwide.[3]
"This submission is another
important milestone for lifitegrast and the millions of patients
living with dry eye disease, which can impact a person's
vision-related quality of life, affecting daily activities such as
reading and using computers," said Howard Mayer, M.D., Head of
Clinical Development, R&D. "Shire is committed to continued
innovation in ophthalmics, where there are opportunities to address
unmet need and improve the lives of patients."
Shire's MAA for lifitegrast is
supported by the largest development program to date for an
investigational-stage dry eye disease candidate, consisting of five
clinical trials with more than 2,500 patients.[4],[5],[6],[7],[8]
In these studies, the signs of dry eye disease were measured using
corneal staining and the symptoms by using patient reported eye
dryness score (EDS).4-8
About the lifitegrast Marketing
Authorization Application
The lifitegrast MAA was submitted via the
Decentralized Procedure (DCP) to Denmark, Norway, Sweden, Finland,
the UK, Germany, the Netherlands, France, Italy, Portugal, Spain
and Greece. The UK is the Reference Member State.
About Dry Eye
Disease
The prevalence of dry eye disease,
with and without symptoms, ranges from 5 to 50% in adults
globally.[9] An eye care
professional can diagnose dry eye disease based on signs and
symptoms and determine management options, which could include the
use of a prescription treatment. Dry eye disease is a
multifactorial disease of the ocular surface that is often chronic
and may be progressive.1 The disease
is most commonly associated with eye dryness and overall eye
discomfort, as well as stinging, burning, or fluctuating blurry
vision.1 Dry eye
disease may significantly affect quality of life and may impact
activities such as reading and using computers.2
Ophthalmologists and eye care
professionals can diagnose dry eye disease based on patient
reported symptoms as well as signs which can be objectively
evaluated through various tests.9
Management options may include the
use of non-prescription and prescription treatments.[10]
Aging and gender are recognized as
traditional risk factors of chronic dry eye disease, while modern
risk factors include prolonged digital/computer screen time,
contact lens wear and cataract or refractive surgery.[11],[12] Dry eye is
a common complaint to ophthalmologists and eye care
professionals.3
About
lifitegrast
Lifitegrast is a lymphocyte
function-associated antigen-1 (LFA-1) antagonist, the first
medication in a new class of drugs. Lifitegrast binds to the
integrin 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), which plays a prominent
role in ocular surface inflammation.6 ICAM-1 may be
over-expressed in corneal and conjunctival tissues in dry eye
disease. LFA-1/ICAM-1 interaction can contribute to formation of an
immunological synapse resulting in T-cell activation and migration
to target tissues.[13] In
vitro studies have shown that lifitegrast may inhibit the
recruitment of previously activated T cells, the activation of
newly recruited T cells, and the release of pro-inflammatory
cytokines-interrupting the perpetual cycle of
inflammation.[14],[15]
About lifitegrast
in the U.S.A.
The U.S. Food and Drug Administration approved lifitegrast under
the brand name Xiidra® (lifitegrast
ophthalmic solution) 5% for the treatment of signs and symptoms of
dry eye disease in July 2016.[16] For more
information on the U.S. prescribing information, click here.
About lifitegrast
clinical studies
Shire's MAA for lifitegrast is
supported by the largest development program to date for an
investigational-stage dry eye disease candidate, consisting of five
clinical trials with more than 2,500 patients.4-8 In four
safety and efficacy studies, lifitegrast improved symptoms as
measured by patient reported eye dryness score (EDS), and in three
of the four studies improved the objective signs of dry eye disease
(measured using corneal staining). A statistically significant
reduction in EDS favoring lifitegrast was seen in all four studies
at week six and week 12 (the week six analysis was a post-hoc
analysis in three studies). In two clinical trials, symptom
improvement was noted at two, six and 12 weeks.4-8
A long-term safety study randomized to either lifitegrast (n=220)
or placebo (n=111) over 360 days found lifitegrast to be generally
well-tolerated with no serious treatment-emergent ocular adverse
events.
The most common adverse reactions
reported in 5 to 25 percent of patients were instillation site
irritation, altered taste sensation (dysgeusia) and reduced visual
acuity.4-8
Shire's
commitment to ophthalmology
Shire officially entered into
ophthalmology with the acquisition of SARcode Bioscience in 2013.
Shire's multi-faceted approach to discovery, development, and
delivery in rare diseases and specialty conditions includes our
efforts to address unmet needs in eye care.
Shire's ophthalmology franchise
has been driven by a combination of strategic acquisitions and
organic growth, and is focused on continuing to expand the
portfolio to include treatment options for anterior and posterior
segment eye conditions. In close to four years, acquisitions
including SARcode followed by Foresight Biotherapeutics helped
bolster Shire's early-, mid- and late-stage ophthalmology pipeline.
As a result of a collaborative license agreement with Parion
Sciences Inc., Shire is developing SHP-659 (formerly P-321),
another investigational candidate for the treatment of dry eye
disease in adults. Shire's ophthalmology pipeline also includes
investigational candidates in infectious conjunctivitis and
glaucoma.
For further information please
contact:
Investor Relations |
|
|
Ian Karp |
ikarp@shire.com |
+1 781 482 9018 |
Robert Coates |
rcoates@shire.com |
+44 1256 894874 |
Media |
|
|
Gwen
Fisher |
gfisher@shire.com |
+1 781
482 9649 |
Clotilde
Houzé |
chouze0@shire.com |
+1 781
266 3567 |
NOTES TO EDITORS
About Shire
Shire is the leading global biotechnology company
focused on serving people with rare diseases. We strive to develop
best-in-class products, many of which are available in more than
100 countries, across core therapeutic areas including Hematology,
Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders,
Gastrointestinal / Internal Medicine / Endocrine and Hereditary
Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared
mission: to develop and deliver breakthrough therapies for the
hundreds of millions of people in the world affected by rare
diseases and other high-need conditions, and who lack effective
therapies to live their lives to the fullest.
www.shire.com
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[1] Gayton, J.
(2009). "Etiology, prevalence, and treatment of dry eye disease".
Clinical Ophthalmology. 3: 405-412.
[2] Miljanovic,
B. et al. (2007). "Impact of Dry Eye Syndrome
on Vision-Related Quality of Life". American
Journal of Ophthalmology. 143(3): 409-415.
[3] O'Brien PD,
Collum LM. (2004). "Dry eye: diagnosis and current treatment
strategies". Curr Allergy Asthma Rep.
4:314-319. Available at:
https://www.ncbi.nlm.nih.gov/pubmed/15175147 [Last accessed August
2017]
[4] Holland E
J, Whitely WO, Sall Ke et al. (2016).
"Lifitegrast clinical efficacy for treatment of signs and symptoms
of dry eye disease across three randomized controlled trials".
Current Medical Research and Opinion. 32(10):
1759-1765.
[5] Sheppard
JD, Torkildsen GL, Lonsdale JD et al. (2014).
"Lifitegrast ophthalmic solution 5.0% for treatment of dry eye
disease: results of the OPUS-1 phase 3 study". Ophthalmology. 121(2): 475-83.
[6] Tauber J,
Karpecki P, Latkany R et al. (2015).
"Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment
of Dry Eye Disease: Results of the Randomized Phase III OPUS-2
Study". Ophthalmology. 122(12): 2423-2431.
[7] Holland E,
Luchs J, Karpecki P et al. (2017). "Lifitegrast for the Treatment
of Dry Eye Disease Results of a Phase III, Randomized,
Double-Masked, Placebo-Controlled Trial (OPUS-3)". Ophthalmology. 124(1): 53-60.
[8] Donnenfeld
E, Karpecki PM, Majmudar PA et al. (2016). "Safety of Lifitegrast
Ophthalmic Solution 5.0% in Patients with Dry Eye Disease: A
1-Year, Multicenter, Randomized, Placebo-Controlled Study".
Cornea. 35: 741-748.
[9] Nelson, J.
Daniel et al. (2017). "TFOS DEWS II
Introduction". The Ocular Surface. 15(3):
269-275.
[10] Vickers
LA, Preeya PK. The Future of Dry Eye Treatment: A Glance into the
Therapeutic Pipeline Ophthalmol Ther 2015 4:69-78
[11] Uchino M
et al. (2013). "Dry Eye Disease: Impact on
Quality of Life and Vision". Curr Ophthalmol
Rep. June; 1(2):51-57.
[12] Hovanesian
JA, Shah SS, et al. (2001). "Symptoms of dry eye and recurrent
erosion syndrome after refractive surgery". J
Cataract Refract Surg. 27:577-84.
[13]
Pflugfelder, S. et al. (2017). "LFA-1/ICAM-1
Interaction as a Therapeutic Target in Dry Eye Disease". Available
at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240001/. [Last
accessed July 2017].
[14] Shire.
(2016). "HIGHLIGHTS OF PRESCRIBING INFORMATION". Available at:
http://www.shirecontent.com/PI/PDFs/Xiidra_USA_ENG.pdf. [Last
accessed July 2017].
[15] DEWS
Research Subcommittee. Research in dry eye: report of the Research
Subcommittee of the International Dry Eye WorkShop (2007). Ocul
Surf. 2007;5(2):179-193.
[16] U.S. Food
& Drug Administration. (2016). "FDA approves new medication for
dry eye disease". Available at:
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm510720.htm.
[Last accessed July 2017].
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Source: Shire plc via Globenewswire
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