J&J’s New Psoriasis Drug Approved by FDA - Drug Discovery and Development

Like many other conditions, a one-size-fits-all therapy does not apply to patients with plaque psoriasis. Now, there is another treatment option for those not responding to current available therapies.

Janssen Biotech, Inc., a division of Johnson & Johnson, has announced U.S. FDA approval of guselkumab (Tremfya) for the treatment of moderate to severe plaque psoriasis.

Approval comes after an expedited regulatory review following application of an FDA Priority Review Voucher. It’s the first drug approved that selectively blocks interleukin (IL)-23, a cytokine thought to play a role in the disease.

The treatment is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. It is indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Regulators made the approval based on results from Phase III clinical studies that included more than 2,000 patients. The VOYAGE 1, VOYAGE 2, and NAVIGATE studies showed 7 out of ten patients receiving the treatment achieved at least 90 percent improvement in skin clearance at week 16.

The VOYAGE 1 AND VOYAGE 2 trials tested guselkumab against placebo and adalimumab (Humira).

Patients receiving guselkumab 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.

In a head-to-head analysis against adalimumab, more than seven out of ten patients treated with guselkumab reported at least 90 percent clearer skin at week 24 compared with more than four out of ten patients treated with adalimumab.

NAVIGATE findings demonstrated the effectiveness of guselkumab in patients who had an inadequate response to treatment with J&J’s IL-12 and IL-23 antagonist ustekinumab (Stelara). At week 28, 31 percent of guselkumab-treated patients were considered cleared or almost cleared versus 14 percent of ustekinumab-treated patients 12 weeks after randomization to continue ustekinumab or transition to guselkumab.

“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 in the company’s announcement. “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.”

“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 in a statement from Janssen. “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.”

There is an ongoing Phase III study evaluating guselkumab as a treatment for active psoriatic arthritis and a Phase III trial evaluating efficacy compared to secukinumab (Cosentyx) for moderate to severe plaque psoriasis.