New Combined Data from the Phase 2 & Phase 3 Teprotumumab Clinical Trials to be Presented during the American Thyroid Associa...
October 24 2019 - 8:00AM
Business Wire
New pooled data from the Phase 2 and Phase 3 clinical trials of
teprotumumab, an investigational medicine being developed by
Horizon Therapeutics plc (Nasdaq: HZNP), will be presented during
an oral plenary presentation at the 89th Annual Meeting of the
American Thyroid Association (ATA) in Chicago on Oct. 31. 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). The Prescription
Drug User Fee Act (PDUFA) goal date is March 8, 2020.
Two posters that highlight findings from a Horizon sponsored
survey of endocrinologists will also be presented. The first poster
illustrates endocrinologists’ perceptions of the impact of TED on
patient quality of life (QoL). The second poster discusses the
treatment strategies used by endocrinologists to help manage this
serious, progressive and vision-threatening disease in patients
with TED.
Presentation Details:
Oral Presentation: Efficacy of Teprotumumab, an Insulin-like
Growth Factor-1 Receptor Antagonist Antibody, in Patients with
Active Thyroid Eye Disease: Pooled Results from Two
Placebo-Controlled Trials
- Speaker: George J. Kahaly, M.D., Ph.D., professor of
medicine and endocrinology and metabolism, Johannes Gutenberg
University Medical Center
- Session: Highlighted Oral Abstracts Session
- Date: Thursday, Oct. 31, 2019
- Time: 8:50-10:05 a.m. Central Time
Poster: Impact of Thyroid Eye Disease on Patient Quality of Life
as Perceived by US Endocrinologists
- Study Author: Anu Sharma, University of Utah School of
Medicine
- Date: Thursday, Oct. 31, 2019
Poster: Trends in thyroid eye disease treatment among US
endocrinologists
- Study Author: Anu Sharma, University of Utah School of
Medicine
- Date: Friday, Nov. 1, 2019
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.6,1 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.2,7 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 disease
becomes inactive – often left with permanent and vision-impairing
consequences.6,1
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 3 OPTIC confirmatory
clinical trial as well as positive Phase 2 results, which were
published in The New England Journal of Medicine. 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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