WEP Clinical today announced a partnership with Horizon Therapeutics plc 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, WEP and Horizon will work together to enable healthcare providers to access TEPEZZA for people living with TED who meet the eligibility criteria. Healthcare 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
Jas Khera, Managing Director of WEP Clinical, said:
“At WEP, we are very pleased to be working with Horizon to help make this much-needed medicine available to patients with Thyroid Eye Disease (TED) in countries where TEPEZZA is not yet approved. Our team is committed to supplying medicines on an unlicensed basis so that patients can potentially access new, innovative treatment options in their country. This new program with Horizon delivers on our commitment and allows us to continue supporting rare disease communities across the globe.”
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.
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.
References
- Barrio-Barrio J, et al. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:1-16.
- 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.
- 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.
- Bothun ED, et al. Update on thyroid eye disease and management. Clinical Ophthalmology. 2009;3:543-551.
