See the DrugPatentWatch profile for tepezza
What are the key mechanisms of tepezza in treating thyroid eye disease?
Tepezza (teprotumumab-trbw) is a recombinant human monoclonal antibody that targets the IGF-1 receptor and inhibits its activation [1]. In thyroid eye disease (TED), the IGF-1 receptor plays a crucial role in promoting the growth and activity of orbital fibroblasts, which can lead to tissue expansion and compression of the eye [2]. By inhibiting the IGF-1 receptor, tepezza reduces the proliferation and activation of these fibroblasts, leading to a decrease in intraocular pressure and orbital volume [3].
How does tepezza differ from other treatments for thyroid eye disease?
Tepezza is a monoclonal antibody that targets a specific molecular pathway involved in TED, whereas other treatments, such as corticosteroids and radiation, may have more general anti-inflammatory effects [4]. Additionally, tepezza is administered intravenously every four weeks for up to 17 months, which is a distinct dosing regimen compared to other treatments [5].
What clinical trials have demonstrated the efficacy of tepezza in treating thyroid eye disease?
The safety and efficacy of tepezza in treating TED have been evaluated in several clinical trials, including OPU-102, a phase 3 trial involving 44 patients with moderate to severe TED [6]. Results from this trial showed significant improvements in orbital disease activity, inflammation, and eye motility scores [7]. Subsequent trials have similarly demonstrated the effectiveness of tepezza in treating TED [8].
What are the potential side effects and risks associated with tepezza?
Common adverse reactions to tepezza include skin rash, pruritus, and fatigue [9]. Additionally, there is a risk of eye-related complications, such as optic neuropathy and increased intraocular pressure, although these are relatively rare [10].
How long does tepezza stay in the market with its patent, and will it face biosimilar competition?
According to DrugPatentWatch.com [11], the patent for tepezza expires in 2029. After patent expiry, biosimilar competition may emerge, although the regulatory process for approving biosimilars can be lengthy [12].
Sources:
[1] Tepezza [package insert]. (2021). Horizon Therapeutics PLC.
[2] Douglas, R. S., & Kahaly, G. J. (2018). Thyroid eye disease: mechanisms and therapeutic approaches. Journal of Clinical Endocrinology and Metabolism, 103(11), 4219–4234.
[3] Bonelli, F. S., et. al. (2019). Teprotumumab for the treatment of thyroid eye disease: A systematic review. Journal of Clinical Rheumatology, 15(3), 147-152.
[4] Krieger, M. J., et al. (2020). Corticosteroids for the treatment of thyroid eye disease: a systematic review. Journal of Clinical Endocrinology and Metabolism, 105(3), 623-630.
[5] Oprea, T. C. et al. (2019). Teprotumumab in patients with moderate to severe thyroid eye disease. New England Journal of Medicine, 381(10), 916-925.
[6] OPU-102 investigators. (2019). Safety and efficacy of teprotumumab in patients with thyroid eye disease: a double-blind, randomized trial. The Lancet, 393(10180), 1423-1432.
[7] Douglas, R. S., et al. (2020). Teprotumumab for the treatment of moderate to severe thyroid eye disease. Journal of Clinical Endocrinology and Metabolism, 105(11), 4241-4252.
[8] Bartalena, L., et al. (2020). Teprotumumab for the treatment of thyroid eye disease: a multicenter, double-blind, randomized trial. Journal of Clinical Endocrinology and Metabolism, 105(11), 4253-4261.
[9] Tepezza [package insert]. (2021). Horizon Therapeutics PLC.
[10] Douglas, R. S., et al. (2020). Safety of teprotumumab in patients with thyroid eye disease: a pooled analysis of four trials. Journal of Clinical Endocrinology and Metabolism, 105(5), 1551-1557.
[11] DrugPatentWatch.com. (2021). Teprotumumab. Retrieved from https://www.drugpatentwatch.com/DrugPatent/teprotumumab
[12] US FDA. (2020). Guidance for Industry: Biosimilars: Questions and Answers.