Guselkumab Granted FDA Approval for Plaque Psoriasis

The FDA on Thursday granted approval to guselkumab (Tremfya) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Guselkumab is a human monoclonal antibody designed to selectively block interleukin (IL)-23. According to a press release, it is the first and only approved biologic that selectively blocks the IL-23 protein.

“Living with plaque psoriasis is challenging, especially the constant pain, itching, and burning,” Patti Janick, a guselkumab trial participant, said in a press release. “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.”

The approval is based on findings from a clinical development program that included more than 2000 patients in the Phase 3 VOYAGE 1, VOYAGE 2, and NAVIGATE studies.

In the VOYAGE 1 and VOYAGE 2 studies, guselkumab demonstrated significant efficacy in patients with moderate to severe plaque psoriasis.

At 16 weeks, at least 7 of 10 patients administered guselkumab achieved at least 90% clearer skin, and more than 80% experienced clearer or almost cleared skin. Improvements were also observed on the scalp and in plaque psoriasis symptoms, including itching, burning, stinging, pain, and skin tightness.

Clearer skin results in patients administered guselkumab were also found to last, with nearly 9 of 10 patients in the guselkumab arm who achieved PASI 90 at week 28 maintaining the response at week 48.

When guselkumab was compared with adalimumab (Humira), more than 7 of 10 patients in the guselkumab arm reported at least 90% clearer skin at week 24 compared with more than 4 of 10 patients administered adalimumab.

“Tremfya represents a significant milestone in the treatment of moderate to severe plaque psoriasis as evidenced by the proven skin clearance demonstrated in teh majority of study patients receiving this IL-23-specific therapy at week 16 and up to week 48,” study investigator Andrew Blauvelt, MD, MBA, said in the release. “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 practicing dermatologist.”

The NAVIGATE study examined the efficacy of guselkumab in patients who had an inadequate response to treatment with ustekinumab (Stelara).

At week 28, the results of the study showed that 31% of patients in the guselkumab arm were considered cleared or almost cleared compared with 14% of patients in the ustekinumab arm 12 weeks after randomization to continue ustekinumab or switch to guselkumab.

“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,” Andrew Greenspan, MD, vice president of Medical Affairs at Janssen, said in a release. “Considering this, we applied a priority review voucher to the application of Tremfya to bring novel treatment to patients sooner.”

Janssen said it will work closely with providers, payers, and pharmacy benefit managers to ensure that guselkumab is widely accessible and affordable for patients.

“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,” Michael Siegel, PhD, vice president of research programs for the National Psoriasis Foundation. “For the more than 1 million Americans living with moderate to severe plaque psoriasis, the approval of Tremfya is a meaningful addition and offers physicians and patients and effective new, first-in-class therapy that selectively inhibits IL-23.”