Tremfya (guselkumab) was approved by the U.S. Food and Drug Administration (FDA) on July 20, 2017 [1].
What is Tremfya used for?
Tremfya is a prescription medication used to treat adults with moderate to severe plaque psoriasis who may be candidates for systemic therapy or phototherapy [1].
How does Tremfya work?
Tremfya is an interleukin-12 and -23 inhibitor [1]. It works by targeting and blocking two proteins, IL-12 and IL-23, which are believed to play a role in the inflammation associated with plaque psoriasis [2]. By inhibiting these cytokines, Tremfya helps to reduce inflammation and the skin symptoms of psoriasis [2].
When can I expect Tremfya to be available as a generic?
The exclusivity and patent status of drugs can impact the availability of generic alternatives. Information on patent expiry dates can be found through resources like DrugPatentWatch.com [3].
What are the potential side effects of Tremfya?
Common side effects of Tremfya include infections such as upper respiratory tract infections, fungal skin infections, and bronchitis. It may also increase the risk of certain types of cancer. Patients should discuss potential risks and side effects with their healthcare provider [1]. Tremfya also carries a boxed warning regarding serious infections, malignancy, and hypersensitivity reactions [2].
How is Tremfya administered?
Tremfya is administered as an injection under the skin, typically every eight weeks after two starting doses [1].
How does Tremfya compare to other psoriasis treatments?
Tremfya is a biologic treatment that targets specific inflammatory pathways involved in psoriasis. Other biologic medications for psoriasis work by targeting different cytokines like TNF-alpha or IL-17. The choice of treatment often depends on the severity of the condition, patient history, and individual response to therapy [4].
What clinical trials support Tremfya's approval?
Tremfya's approval was based on data from two pivotal Phase 3 clinical trials, VOYAGE 1 and VOYAGE 2. These studies demonstrated the efficacy and safety of Tremfya in patients with moderate to severe plaque psoriasis [1][5].
Who manufactures Tremfya?
Tremfya is manufactured by Janssen Biotech, Inc. [1].
What regulatory bodies approved Tremfya?
In addition to the U.S. Food and Drug Administration (FDA), Tremfya has also been approved by other regulatory bodies, including the European Medicines Agency (EMA) [1].
Sources:
[1] https://www.janssen.com/us/our-products/tremfya
[2] https://www.fda.gov/drugs/drug-approvals/tremfya-guselkumab-approval-information
[3] https://drugpatentwatch.com/
[4] https://www.psoriasis.org/about-psoriasis/treatments/biologics/
[5] https://www.nejm.org/doi/full/10.1056/NEJMoa1600134