The recent first global approval of guselkumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

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.[3] 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.[1]

According to the International Federation of Psoriasis Associations, more than 125 million people worldwide have psoriasis and/or psoriatic arthritis.[4]  With an approximate 150,000 new cases being observed within the US each year; 80% of these will be the plaque-type.[5]

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.[6] The major phase 3 studies cited were the VOYAGE 1[7], VOYAGE 2[8] and NAVIGATE[9] studies. This biological agent is also in preregistration phase in Canada, Japan and the EU for plaque psoriasis. [2]

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[6]: maintenance therapy is recommended as once every 8 weeks. [3]

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.” [6]

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.” [6]

For further information related to the first approval of guselkumab please visit Drugs[1],  or to learn more about the overall development of guselkumab across all indications visit AdisInsight[2].

Image credit: Khlongwangchao / iStock

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