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news.Johnson & Johnson (J&J) subsidiary Janssen Biotech has secured approval from the US Food and Drug Administration (FDA) for its Tremfya (guselkumab) to treat adults with moderate to severe plaque psoriasis.
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The company has received approval for Tremfya to treat adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Tremfya is a human monoclonal antibody that selectively blocks the protein interleukin (IL)-23, which plays a crucial role in plaque psoriasis.
It will be administered as a 100mg subcutaneous injection every eight weeks following two starter doses at weeks zero and 4.
The approval was based on results from a clinical development program, which comprised of more than 2,000 patients in the Phase 3 Voyage 1, Voyage 2 and Navigate studies.
A Phase 3 study assessing Tremfya to treat active psoriatic arthritis is ongoing, while Phase 3 program assessing the efficacy of Tremfya compared with Cosentyx (secukinumab) to treat moderate to severe plaque psoriasis is underway.
The study investigator Dr Andrew Blauvelt said: “Tremfya 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.
“We continue to make progress in understanding the science of psoriasis and the important role IL-23 plays in the pathogenesis of this disease, which is another reason why today’s approval of Tremfya is exciting, both as a researcher and a practicing dermatologist.”
Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.