Janssen Biotech announced that the US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Approval comes after an expedited regulatory review following application of an FDA Priority Review Voucher.

 Tremfya is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. In clinical studies, patients receiving Tremfya experienced significant improvement in skin clearance and greater improvement in symptoms of plaque psoriasis including itch, pain, stinging, burning and skin tightness when compared with placebo at week 16. Superior results in skin clearance (PASI 90) were demonstrated with Tremfya compared with Humira (adalimumab) at weeks 16, 24 and 48.

"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," said Andrew Blauvelt, M.D., M.B.A., president of Oregon Medical Research Center, and study investigator. "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."

"Living with plaque psoriasis is challenging, especially the constant pain, itching and burning," said Patti Janick, a guselkumab clinical trial participant. "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."

Tremfya received FDA approval based on results from a clinical development program that included more than 2,000 patients in the Phase 3 VOYAGE 1, VOYAGE 2 and NAVIGATE studies, which have been published in peer-reviewed journals and were presented at the 25th European Academy of Dermatology and Venerology Congress and the 2017 American Academy of Dermatology Annual Meeting.

Results from VOYAGE 1 and VOYAGE 2 demonstrated significant efficacy in patients with moderate to severe plaque psoriasis treated with Tremfya. In clinical studies, at 16 weeks, at least seven out of ten Tremfya-treated patients achieved at least 90 percent clearer skin, and more than 80 percent demonstrated cleared or almost cleared skin. Improvements were also demonstrated with Tremfya in psoriasis involving the scalp and in symptoms of plaque psoriasis including itch, pain, stinging, burning and skin tightness at week 16. Treatment with Tremfya resulted in clearer skin that lasted, as nearly nine out of ten Tremfya-treated patients who achieved PASI 90 at week 28 maintained that response at week 48. Versus Humira, at week 24, more than seven out of ten patients treated with Tremfya reported at least 90 percent clearer skin compared with more than four out of ten patients treated with Humira.

Navigate findings demonstrated the effectiveness of tremfya in patients who had an inadequate response to treatment with Stelara (ustekinumab). At week 28, 31 percent of Tremfya-treated patients were considered cleared or almost cleared versus 14 per cent of Stelara-treated patients 12 weeks after randomization to continue Stelara or transition to Tremfya.

"Addressing the need for additional safe and effective plaque psoriasis therapies has been a critical area of focus at Janssen for more than 15 years," said Andrew Greenspan, M.D., Vice President of Medical Affairs at Janssen. "Considering this, we applied a priority review voucher to the application for Tremfya to bring this novel treatment to patients sooner."

"The approval of new and effective treatment options is always welcome news for the plaque psoriasis patient community, as not all patients respond similarly to currently available treatments," said Michael Siegel, Ph.D., vice president of Research Programs for the National Psoriasis Foundation. "For the more than one million Americans living with moderate to severe plaque psoriasis, the approval of Tremfya is a meaningful addition and offers physicians and patients an effective new, first-in-class therapy that selectively inhibits IL-23."

Janssen will work closely with payers, providers and pharmacy benefit managers to ensure Tremfya is broadly accessible and affordable for patients and that the cost for payers is competitive with currently available biologic therapies for psoriasis. Janssen offers a number of patient support programs, including a co-pay card for patients with commercial insurance that reduces their out-of-pocket cost for Tremfya to no more than $5 per dose.

Efficacy Evaluation

The Tremfya versus placebo analysis is based on the results of an analysis of 101 global sites from VOYAGE 1 and 115 global sites from VOYAGE 2 (including North American sites [i.e., US and Canada]).

The Tremfya versus Humira analysis is based on the results of an analysis of 38 North American sites (US=27, Canada=11) from VOYAGE 1 and 41 North American sites (US=31, Canada=10) from VOYAGE 2 that utilized US-licensed Humira.