Clinical Study Data Highlighting the Impact of Teprotumumab in Patients With Active Thyroid Eye Disease to Be Presented Durin...
November 04 2019 - 8:30AM
Business Wire
Horizon Therapeutics plc (Nasdaq: HZNP) today announced an
integrated analysis of efficacy data from the Phase 2 and Phase 3
clinical trials of teprotumumab will be presented during an oral
session at the American College of Rheumatology (ACR) Annual
Meeting, Nov. 8-13 in Atlanta. The U.S. Food and Drug
Administration is currently evaluating under Priority Review a
Biologics License Application (BLA) for teprotumumab in the
treatment of active thyroid eye disease (TED). If approved,
teprotumumab would be the first FDA-approved medicine for active
TED. The Prescription Drug User Fee Act (PDUFA) goal date is March
8, 2020. Teprotumumab is an investigational medicine and its safety
and efficacy have not been established.
Presentation Details:
- Oral Presentation: Teprotumumab, A Novel Biologic for
Active Thyroid Eye Disease (abstract 1807)
- Speaker: Raymond Douglas, M.D., Ph.D., director of the
Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical
Center
- Date: Monday, Nov. 11
- Time: 2:45-3 p.m. ET
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 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.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the potential regulatory approval of
teprotumumab and associated timing. 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 FDA will approve teprotumumab as a
treatment for active TED on the timeline Horizon expects or at all.
For a further description of these and other risks facing Horizon,
please see the risk factors described in Horizon's filings with the
United States Securities and Exchange Commission, including those
factors discussed under the caption “Risk Factors” in those
filings. Forward-looking statements speak only as of the date of
this press release and Horizon undertakes no obligation to update
or revise these statements, except as may be required by law.
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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