Horizon Therapeutics plc Trading Halted Today; FDA Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) Meeting to Disc...
December 13 2019 - 7:00AM
Business Wire
Horizon Therapeutics plc (Nasdaq: HZNP) today announced that
NASDAQ has halted trading of the Company’s common stock. As per the
U.S. Food and Drug Administration (FDA) guidelines for new
molecular entities (NMEs), the FDA Dermatologic and Ophthalmic
Drugs Advisory Committee (DODAC) is holding a meeting today from 8
a.m. to 4 p.m. ET to discuss teprotumumab, an investigational
medicine for the treatment of Thyroid Eye Disease (TED).
Teprotumumab is an investigational medicine and its safety and
efficacy have not been established.
About Thyroid Eye Disease
Thyroid Eye Disease (TED) is a serious, progressive and
vision-threatening autoimmune disease with a limited window of
activity that can last up to three years.1,2,3 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 signaling complex on cells within the orbit.4,5
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.1,6 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.2,7 TED has only been shown to respond to pharmacotherapy
while the disease is active and inflammation is ongoing.8
Currently, patients must live with active TED until the
inflammation subsides, after which they are often left with
permanent and vision-impairing consequences.1,6
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 Priority Review, Orphan Drug,
Fast Track and Breakthrough Therapy designations from the FDA. The
clinical development program for teprotumumab in the treatment of
TED includes positive results from the Phase 2 clinical study,
which were published in The New England Journal of Medicine, as
well as positive results from the Phase 3 OPTIC confirmatory
clinical trial. The OPTIC trial was conducted at leading centers in
the U.S., Germany and Italy, with co-principal investigators
Raymond Douglas, M.D., Ph.D., Cedars-Sinai Medical Center and
George Kahaly, M.D., Ph.D., Johannes Gutenberg University Medical
Center. Horizon is also conducting the OPTIC‐X extension trial to
gather further insight into the long-term efficacy and safety of
teprotumumab.
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 Facebook or explore career opportunities on
LinkedIn.
References
- Barrio-Barrio J, et al. Graves’ Ophthalmopathy: VISA versus
EUGOGO Classification, Assessment and Management. Journal of
Ophthalmology. 2015.
https://www.hindawi.com/journals/joph/2015/249125/cta/. Accessed
Feb 22, 2019.
- Ross DS, et al. 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. Accessed Feb 22,
2019.
- Shan SJ, Douglas RS. The Pathophysiology of Thyroid Eye
Disease. Journal of Neuro-Ophthalmology. 2014; 34: 177-185.
- Bahn RS. Graves' Ophthalmopathy. The New England Journal of
Medicine. 25 February 2010.
https://www.nejm.org/doi/full/10.1056/NEJMra0905750. Accessed Feb
22, 2019.
- Pritchard J, et al. 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. Accessed Feb 22,
2019.
- Bothun ED, et al. Update on thyroid eye disease and management.
Clinical Ophthalmology. 19 October 2009.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770865/. Accessed Feb
22, 2019.
- McKeag D, et al. 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. Accessed Feb 22,
2019.
- Mamoojee Y, Pearce SHS. Natural History. In: Wiersinga WM,
Kahaly GJ (eds): Graves’ Orbitopathy: A Multidisciplinary Approach
– Questions and Answers. Basel, Karger. 2017:93-104.
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Tina Ventura Senior Vice President, Investor Relations
Investor-relations@horizontherapeutics.com
Ruth Venning Executive Director, Investor Relations
Investor-relations@horizontherapeutics.com
U.S. Media Contacts: Matt Flesch Vice President,
Communications and Patient Advocacy
media@horizontherapeutics.com
Rachel Vann Associate Director, Product Communications
media@horizontherapeutics.com
Ireland Media Contact: Gordon MRM Ray Gordon
ray@gordonmrm.ie
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