New TEPEZZA® (teprotumumab-trbw) Data to Be Presented at the American Academy of Ophthalmology 2020 Annual Meeting
October 30 2020 - 8:00AM
Business Wire
-- Oral presentation will highlight results
from the OPTIC 48-week off-treatment follow-up period, including
long-term proptosis (eye bulging) response and diplopia (double
vision) improvement --
-- Poster presentation assesses improvement in
fellow eye of patients with TED, indicating potential benefits in
less severe disease --
Horizon Therapeutics plc (Nasdaq: HZNP) today announced new
TEPEZZA® (teprotumumab-trbw) data being presented at the American
Academy of Ophthalmology Annual Meeting (AAO 2020 Virtual), Nov.
13-15, 2020. TEPEZZA is the first and only medicine approved by the
U.S. Food and Drug Administration (FDA) for the treatment of TED –
a serious, progressive and vision-threatening rare autoimmune
disease.1
TEPEZZA data being presented at AAO 2020 Virtual include:
- Long-Term Assessment of Proptosis and Diplopia from the
OPTIC Trial of Teprotumumab in Thyroid Eye Disease
- Session: PA038, R. Douglas
- Date: On Demand (oral presentation)
- Improvement in the Fellow Eye of Patients With TED: Pooled
Analyses from the Teprotumumab Studies
- Session: PO305, R. Douglas
- Date: On Demand (scientific poster)
- Dysthyroid Optic Neuropathy Response to Teprotumumab: Early
Response to Therapy
- Session: PO307, C. Sears
- Date: On Demand (scientific poster) Independent
study
- What Every Ophthalmologist Should Know About
Teprotumumab
- Session: OCU03V, R. Douglas
- Date: Friday, Nov. 13, 2020; 1:07 p.m. PT (live
broadcast)
- Plastics: Biologics for Orbital Disease (teprotumumab)
- Session: SYM17V, R. Douglas
- Date: Sunday, Nov. 15, 2020; 2:05 p.m. PT (live
broadcast)
In addition, Horizon will host a virtual product theater on
Friday, Nov. 13 at 4:30 p.m. PT about TEPEZZA, featuring Raymond
Douglas, M.D., Ph.D., director of the Orbital and Thyroid Eye
Disease Program, Cedars-Sinai Medical Center.
About Thyroid Eye Disease (TED)
TED is a serious, progressive and vision-threatening rare
autoimmune disease.1 TED often occurs in people living with
hyperthyroidism or Graves’ disease; however, it is a distinct
disease that is caused by autoantibodies activating an
IGF-1R-mediated signaling complex on cells within the retro-orbital
space.2,3 This leads to a cascade of negative effects, which may
cause long-term, irreversible damage. As TED progresses, the
serious damage it can cause includes proptosis (eye bulging),
strabismus (misalignment of the eyes) and diplopia (double vision)
– and in some cases can lead to blindness.4,5
About TEPEZZA
INDICATION
TEPEZZA is indicated for the treatment of Thyroid Eye
Disease.
IMPORTANT SAFETY INFORMATION Warnings and Precautions
Infusion Reactions: TEPEZZA may cause infusion reactions.
Infusion reactions have been reported in approximately 4% of
patients treated with TEPEZZA. Reported infusion reactions have
usually been mild or moderate in severity. Signs and symptoms may
include transient increases in blood pressure, feeling hot,
tachycardia, dyspnea, headache and muscular pain. Infusion
reactions may occur during an infusion or within 1.5 hours after an
infusion. In patients who experience an infusion reaction,
consideration should be given to premedicating with an
antihistamine, antipyretic, or corticosteroid and/or administering
all subsequent infusions at a slower infusion rate.
Preexisting Inflammatory Bowel Disease: TEPEZZA may cause
an exacerbation of preexisting inflammatory bowel disease (IBD).
Monitor patients with IBD for flare of disease. If IBD exacerbation
is suspected, consider discontinuation of TEPEZZA.
Hyperglycemia: Increased blood glucose or hyperglycemia
may occur in patients treated with TEPEZZA. In clinical trials, 10%
of patients (two-thirds of whom had preexisting diabetes or
impaired glucose tolerance) experienced hyperglycemia.
Hyperglycemic events should be managed with medications for
glycemic control, if necessary. Monitor patients for elevated blood
glucose and symptoms of hyperglycemia while on treatment with
TEPEZZA. Patients with preexisting diabetes should be under
appropriate glycemic control before receiving TEPEZZA.
Adverse Reactions
The most common adverse reactions (incidence ≥5% and greater
than placebo) are muscle spasm, nausea, alopecia, diarrhea,
fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and
dry skin.
For additional information on TEPEZZA, please see Full
Prescribing Information at TEPEZZAhcp.com.
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 and follow us on Twitter,
LinkedIn, Instagram and Facebook.
References
- Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus
EUGOGO Classification, Assessment, and Management. Journal of
Ophthalmopathy. 2015;2015:1-16.
- Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in
Thyroid Associated Ophthalmopathy. Autoimmunity.
1993;16(4):251–257.
- Pritchard J, et al. Immunoglobulin Activation of T Cell
Chemoattractant Expression in Fibroblasts from Patients with
Graves’ Disease Is Mediated Through the Insulin-Like Growth Factor
1 Receptor Pathway. J Immunol. 2003;170:6348-6354.
- Bartalena L, et al. The 2016 European Thyroid
Association/European Group on Graves' Orbitopathy Guidelines for
the Management of Graves' Orbitopathy. Eur Thyroid J.
2016;5(1):9-26.
- McKeag D, et al. Clinical features of dysthyroid optic
neuropathy: a European Group on Graves' Orbitopathy (EUGOGO)
survey. Br J Ophthalmol. 2007;91:455-458.
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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: Rachel Vann Director, Product
Communications media@horizontherapeutics.com
Ireland Media Contact: Gordon MRM Ray Gordon
ray@gordonmrm.ie
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