Horizon Therapeutics plc Announces Short-Term TEPEZZA® (teprotumumab-trbw) Supply Disruption Due to Government-Mandated (Operation Warp Speed) COVID-19 Vaccine Production
Horizon Therapeutics plc Announces Short-Term TEPEZZA® (teprotumumab-trbw) Supply Disruption Due to Government-Mandated (Operation Warp Speed) COVID-19 Vaccine Production
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TEPEZZA is a biologic approved for the treatment of Thyroid Eye Disease (TED), which is a rare, serious, progressive and vision-threatening autoimmune disease.1 There are no FDA-approved alternative treatments for TED.
“We appreciate the efforts Operation Warp Speed and the Administration are taking to accelerate the COVID-19 vaccine production to save lives and put an end to the pandemic,” said
The Company does not anticipate the short-term supply disruption to impact its full-year 2020 financial guidance, including its previously announced full-year 2020 TEPEZZA guidance of more than
Consistent with past practice, the Company expects to issue 2021 guidance in connection with its fourth-quarter 2020 earnings call when the Company expects to have additional information regarding TEPEZZA supply.
Information for patients
Beginning today, Horizon is delaying new patients starting on TEPEZZA. The Company will be communicating with TEPEZZA patients currently on therapy and the physicians who treat them. The Company’s priority will be to resume therapy for those patients as quickly as possible. If patients have additional questions, please contact Horizon Patient Services at 1-833-469-8331.
Information for healthcare professionals
Physicians with questions should call 1-866-479-6742 [Option 1] or email medicalinformation@horizontherapeutics.com.
Call Information
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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
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Barrio-Barrio J, et al. Graves' Ophthalmopathy:
VISA versus EUGOGO Classification, Assessment and Management.Journal of Ophthalmopathy . 2015;2015:1-16.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the anticipated impact of recent government orders on TEPEZZA supply, Horizon’s financial and operating results, and planned clinical trials; expectations regarding the length of TEPEZZA supply disruptions; Horizon’s full-year 2020 financial guidance and guidance with respect to 2020 TEPEZZA sales; Horizon’s expected cash position at
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.
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Horizon contacts:
Senior Vice President, Investor Relations
Investor-relations@horizontherapeutics.com
Executive Director, Investor Relations
Investor-relations@horizontherapeutics.com
Executive Vice President, Corporate Affairs & Chief Communications Officer
media@horizontherapeutics.com
Ireland Media Contact:
Gordon MRM
ray@gordonmrm.ie
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