The initial release date for Tremfya (guselkumab) in the United States was July 20, 2017 [1]. This approval was granted by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults [1].
When did Tremfya get approved in other regions?
In Europe, Tremfya received marketing authorization from the European Medicines Agency (EMA) on September 11, 2017 [2]. It is approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy [2].
What is Tremfya used for?
Tremfya is a medication used to treat adults with moderate to severe plaque psoriasis [1, 2]. Plaque psoriasis is a chronic autoimmune disease that causes the rapid buildup of skin cells, leading to thick, silvery scales and itchy, dry, red patches [3]. Tremfya works by targeting a specific protein in the body called interleukin-23 (IL-23), which plays a role in the inflammatory processes associated with psoriasis [4].
How effective is Tremfya?
Clinical trials have demonstrated Tremfya's effectiveness in clearing skin. In the VOYAGE 1 and VOYAGE 2 studies, a significant percentage of patients treated with Tremfya achieved 90% or greater skin improvement (sPGA 90) at week 16 and maintained this response through week 52 [5]. These studies also showed high rates of skin clearance (sPGA 100) and minimal disease activity [5].
What are the common side effects of Tremfya?
Common side effects reported with Tremfya include upper respiratory infections, headache, and injection site reactions [1]. Less common but more serious side effects can include an increased risk of infections, including serious infections [1]. Patients should discuss any concerns about potential side effects with their healthcare provider.
When does Tremfya's patent expire?
Information regarding the specific patent expiry dates for Tremfya is available through specialized databases. DrugPatentWatch.com tracks patent information for pharmaceuticals, which can provide details on when patents for Tremfya are set to expire [6]. Generally, the exclusivity period for a drug can be influenced by various factors, including patent challenges and the granting of new patents for different indications or formulations.
Are there any alternatives to Tremfya?
Several other biologic medications are available for the treatment of moderate to severe plaque psoriasis. These include drugs that target different inflammatory pathways, such as TNF-alpha inhibitors (e.g., adalimumab, etanercept), IL-17 inhibitors (e.g., secukinumab, ixekizumab), and IL-12/23 inhibitors (e.g., ustekinumab) [7]. The choice of treatment depends on individual patient factors, disease severity, and physician recommendation.
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1. U.S. Food and Drug Administration. (2017, July 21). FDA approves Tremfya (guselkumab) for moderate to severe plaque psoriasis. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremfya-guselkumab-moderate-severe-plaque-psoriasis
2. European Medicines Agency. (2017, September 11). Tremfya. https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya
3. National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis/
4. Tremfya Prescribing Information. Janssen Biotech, Inc.
5. Reich, K., Armstrong, A. W., Thaçi, D., Wu, W., Wu, J., et al. (2017). Guselkumab in moderate-to-severe psoriasis. New England Journal of Medicine, 376(16), 1521-1532. https://www.nejm.org/doi/full/10.1056/NEJMoa1610045
6. DrugPatentWatch.com. https://drugpatentwatch.com/
7. Menter, A., Strober, B. E., Kaplan, D. H., Felten, D. A., Lineberry, M. D., et al. (2020). Joint AAD-NPF guidelines of care for the management of psoriasis with biologics part 1: azathioprine, cyclosporine, methotrexate, mycophenolic acid, and other systemic agents. Journal of the American Academy of Dermatology, 82(2), 461-487.e5. https://www.jaad.org/article/S0190-9622(19)32700-9/fulltext