Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)
Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)
“There is a major unmet need for an effective therapy for active thyroid eye disease, a painful and sight-threatening disease with no
The teprotumumab BLA submission includes results from the Phase 3 confirmatory clinical trial, called OPTIC (Treatment of Graves’ Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study), as well as positive Phase 2 results. Results from OPTIC were presented at the 2019
About Thyroid Eye Disease (TED)
TED is a progressive and debilitating autoimmune disease with a limited window of active disease during which it may respond to medical intervention.1,2 While TED often occurs in people living with hyperthyroidism or Graves’ disease, it is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signalling complex on cells within the orbit.3,4 This leads to a cascade of negative effects, which may cause long-term, irreversible damage. Active TED lasts for up to three years and is characterized by inflammation and tissue expansion behind the eye.5,1 As TED progresses, it causes serious damage – including proptosis (eye bulging), strabismus (misalignment of the eyes), and diplopia (double vision) – and in some cases can lead to blindness.2,6 Currently, patients must suffer through Active TED until the disease becomes inactive – often left with permanent and sight-impairing consequences.5,1 People living with TED often experience long-term functional, psychological and economic burdens, including inability to work and perform activities of daily living.7,8 There are currently no
About Teprotumumab
Teprotumumab is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R). Teprotumumab has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the
About Horizon
Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com, follow us @HorizonNews on Twitter, like us on
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the FDA’s review of the teprotumumab BLA, potential regulatory approval of teprotumumab and the potential for teprotumumab as a treatment for TED. Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding whether the
References
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Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management.
Journal of Ophthalmology . 2015. https://www.hindawi.com/journals/joph/2015/249125/cta/. AccessedFeb 22, 2019 . -
The 2016
European Thyroid Association /European Group on Graves' Orbitopathy Guidelines for the Management of Graves' Orbitopathy.European Thyroid Journal .2 March 2016 . https://www.ncbi.nlm.nih.gov/pubmed/27099835. AccessedFeb 22, 2019 . -
Graves' Ophthalmopathy.
The New England Journal of Medicine .25 February 2010 . https://www.nejm.org/doi/full/10.1056/NEJMra0905750. AccessedFeb 22, 2019 . -
Igs from patients with Graves' disease induce the expression of T cell chemoattractants in their fibroblasts.
The Journal of Immunology .15 January 2002 . https://www.ncbi.nlm.nih.gov/pubmed/11777993. AccessedFeb 22, 2019 . -
Update on thyroid eye disease and management. Clinical Ophthalmology.
19 October 2009 . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770865/. AccessedFeb 22, 2019 . -
Clinical features of dysthyroid optic neuropathy: a
European Group on Graves' Orbitopathy (EUGOGO) survey.British Journal of Ophthalmology .11 October 2006 . https://www.ncbi.nlm.nih.gov/pubmed/17035276. AccessedFeb 22, 2019 . -
Quality of Life and Occupational Disability in Endocrine Orbitopathy.
DA International .24 April 2009 . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2689575/. AccessedFeb 22, 2019 . -
Public health relevance of Graves' orbitopathy.
The Journal of Clinical Endocrinology & Metabolism .26 November 2012 . https://www.ncbi.nlm.nih.gov/pubmed/23185037. AccessedFeb 22, 2019 .
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Source:
Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizontherapeutics.com
Ruth Venning
Executive Director, Investor Relations
Investor-relations@horizontherapeutics.com
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Matt Flesch
Executive Director, Product Communications
media@horizontherapeutics.com
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Gordon MRM
Ray Gordon
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