The recent first global approval of guselkumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
In July 2017, guselkumab (Tremfya™), developed by Janssen Biotech Inc., received its first global approval in the US for use in adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Guselkumab, administered via subcutaneous injection, is a human monoclonal antibody that specifically inhibits interleukin (IL)-23-specific intracellular and downstream signalling. IL-23 plays a key role in the inflammatory processes believed to be involved with the development and maintenance of chronic immune-mediated diseases including plaque psoriasis and psoriatic arthritis.
According to the International Federation of Psoriasis Associations, more than 125 million people worldwide have psoriasis and/or psoriatic arthritis. With an approximate 150,000 new cases being observed within the US each year; 80% of these will be the plaque-type.
Guselkumab is the first and only biologic drug approved for this indication that selectively blocks IL-23. The drug was approved following the application of an FDA Priority Review Voucher, and based on the positive results from the clinical program involving over 2000 patients globally. The major phase 3 studies cited were the VOYAGE 1, VOYAGE 2 and NAVIGATE studies. This biological agent is also in preregistration phase in Canada, Japan and the EU for plaque psoriasis. 
Janssen has stated it will work with consumers to ensure guselkumab is cost-competitive with other biologic treatments for psoriasis, and that through patient support programmes such as the co-pay card for those with commercial insurance, the out-of-pocket costs should be “no more than US$5 per dose”: maintenance therapy is recommended as once every 8 weeks. 
Study investigator Andrew Blauvelt, M.D., M.B.A., President of Oregon Medical Research Center praised the approval of guselkumab saying that it “represents a significant milestone in the treatment of moderate to severe plaque psoriasis as evidenced by the proven skin clearance demonstrated in the majority of study patients receiving this IL-23–specific therapy at week 16 and up to week 48.” 
Study participant Patti Janick agreed, explaining that “Living with plaque psoriasis is challenging, especially the constant pain, itching and burning. I am encouraged by the results I’ve experienced with TREMFYA™ and the possibility it offers others living with plaque psoriasis to find similar relief and clearer skin.” 
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