New TEPEZZA® (teprotumumab-trbw) Data to Be Presented at the American Academy of Ophthalmology 2020 Annual Meeting

Rhea-AI Summary

Horizon Therapeutics (Nasdaq: HZNP) presented new data on TEPEZZA® (teprotumumab) at the American Academy of Ophthalmology Annual Meeting. TEPEZZA is the first and only FDA-approved treatment for Thyroid Eye Disease (TED), a rare autoimmune disorder. Key presentations include a long-term assessment of proptosis from the OPTIC trial, improvement in fellow eyes of TED patients, and early responses to therapy. A virtual product theater featuring Dr. Raymond Douglas will also occur on November 13, 2020. TEPEZZA's infusion reactions and potential side effects like hyperglycemia were emphasized in the safety information.

Positive

• First and only FDA-approved treatment for Thyroid Eye Disease.
• Presentation of critical data at AAO 2020 could enhance awareness and adoption of TEPEZZA.
• Engagement with the medical community through presentations and product theater.

Negative

• Risk of infusion reactions in 4% of patients treated with TEPEZZA.
• Potential exacerbation of preexisting inflammatory bowel disease.
• Hyperglycemia reported in 10% of patients during clinical trials.

DUBLIN--(BUSINESS WIRE)--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

1. Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:1-16.
2. Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257.
3. 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.
4. 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.
5. 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.