TEPEZZA® (teprotumumab) Approved in Brazil for the Treatment of Active Thyroid Eye Disease (TED)

-- First and only medicine approved in Brazil for the treatment of active TED, a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease --

DUBLIN--(BUSINESS WIRE)-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced the Brazilian Health Regulatory Agency (ANVISA) has approved TEPEZZA for the treatment of active TED. TEPEZZA is the first and only medicine approved for active TED in Brazil, filling a significant unmet need for those who are living with this progressive autoimmune disease that can threaten vision.

“Brazil is now the first country outside of the United States to approve TEPEZZA and this further reinforces our commitment to the global rare disease community,” said Vikram Karnani, executive vice president and president, global commercial operations and medical affairs, Horizon. “The TED community in Brazil now has an approved medicine that has been proven in clinical studies and over three years of real-world use in the United States to treat the debilitating symptoms of TED, such as eye bulging, double vision and pain.”

The approval was based on the OPTIC Phase 3 clinical trial that served as the basis for the U.S. Food and Drug Administration (FDA) approval of TEPEZZA in January 2020. In the trial, 83% of patients treated with TEPEZZA had a meaningful improvement in proptosis, or eye bulging, (≥2 mm) at Week 24 compared with those who were treated with placebo (p˂0.001). TEPEZZA was also shown to improve diplopia, reduce orbital pain, redness and swelling, and improve functional vision and patient appearance.¹

Horizon is also conducting three clinical trials for TEPEZZA in TED, including a Phase 4 post-marketing study (NCT05002998) with sites in the United States and Europe, as well as two Phase 3 clinical trials in Japan. The first trial in Japan (OPTIC-J) is evaluating TEPEZZA for the treatment of TED patients with disease duration of nine months or less and high clinical activity score (CAS), which is a measure of disease activity. The second is evaluating TEPEZZA for the treatment of adults with disease duration of two to ten years and low CAS.

About Thyroid Eye Disease (TED)

TED is a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease.² TED often occurs in people living with Graves’ disease, but it is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.^3,4 This leads to a cascade of negative effects, which may cause long-term, irreversible damage, including blindness. Signs and symptoms of TED may include dry eyes and grittiness; redness, swelling and excessive tearing; eyelid retraction; proptosis; pressure and/or pain behind the eyes; and diplopia.^5,6

About TEPEZZA

BRAZIL INDICATION

TEPEZZA is indicated for the treatment of active Thyroid Eye Disease (also known as Graves' orbitopathy and Graves' ophthalmopathy).

U.S. INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease, regardless of Thyroid Eye Disease activity or duration.

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 controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while 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, dry skin, weight decreased, nail disorders, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.com for more information.

About Horizon

Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory 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, visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits of TEPEZZA. These forward-looking statements are based on management 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 the actual timing of launching TEPEZZA in Brazil and other markets, whether TEPEZZA is successfully commercialized, and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon’s filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.

References

1. TEPEZZA (teprotumumab-trbw) prescribing information Horizon.
2. Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:249125.
3. Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257.
4. 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.
5. Bartalena L, et al. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67.
6. 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.

C-HZN-US-00193

View source version on businesswire.com: https://www.businesswire.com/news/home/20230626667763/en/

Investors:

Tina Ventura

Senior Vice President, Chief Investor Relations Officer

Investor-relations@horizontherapeutics.com

U.S. Media:

Rachel Vann

Senior Director, Product Communications

media@horizontherapeutics.com

Ireland Media:

Eimear Rigby

Associate Director, Corporate Communications

media@horizontherapeutics.com

Source: Horizon Therapeutics plc