Named Patient Use Program for TEPEZZA® (teprotumumab-trbw)

Horizon Therapeutics plc Announces Partnership with WEP Clinical to Launch Named Patient Use Program for TEPEZZA® (teprotumumab-trbw)

-- Program may enable health care providers to access TEPEZZA for people living with TED who meet certain eligibility criteria --

May 17, 2021

Horizon Therapeutics plc today announced a partnership with WEP Clinical to make a Named Patient Use (NPU) Program available for TEPEZZA. The TEPEZZA NPU program is for patients with Thyroid Eye Disease (TED) in countries where TEPEZZA is not approved by the country’s local regulatory authority.

The TEPEZZA NPU Program is designed to provide an avenue for physicians – contingent on meeting the necessary eligibility criteria and receiving local health approval – to potentially prescribe TEPEZZA on behalf of patients who live in certain countries where it is not available. TEPEZZA is currently only approved by the United States Food and Drug Administration (FDA) for the treatment of TED. It is not currently approved by regulatory authorities in any country other than the United States.

Through the NPU Program, Horizon and WEP will work together to enable health care providers to access TEPEZZA for people living with TED who meet the eligibility criteria. Health care professionals can inquire for more details about TEPEZZA and the NPU Program by emailing TED@wepclinical.com.

TED is a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation and facial disfigurement.1,2,3 Patients without treatment options have to live with TED until the inflammation subsides, after which they are often left with permanent and vision-impairing consequences.1,4

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, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

About WEP Clinical
Established in 2008, WEP Clinical is a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available. We have offices located in London, United Kingdom; RTP North Carolina, United States; Lisbon, Portugal; and Dublin, Ireland and possess all the necessary licenses allowing us to meet drug access and distribution needs across all regions, worldwide. We are passionate about helping those in need. For more information, please visit www.wepclinical.com.

Forward Looking Statements
This release contains forward-looking statements, including, but not limited to, statements related to the anticipated initiation of the TEPEZZA NPU program and availability of TEPEZZA under the program to patients outside of the United States; and business and other statements that are not historical facts. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk of future supply disruptions; impacts of the COVID-19 pandemic and actions taken to slow its spread; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon operates 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 release as a result of new information.

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.

References

  1. Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:1-16.
  2. Ross DS, 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.
  3. 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.
  4. Bothun ED, et al. Update on thyroid eye disease and management. Clinical Ophthalmology. 2009;3:543-551.

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