FDA approves Tremfya for psoriasis

Janssen Biotech announced that the FDA has approved Tremfya for treating adults with moderate-to-severe psoriasis who are candidates for systemic therapy or phototherapy.

Tremfya (guselkumab), a human monoclonal antibody, is the only approved biologic therapy that selectively blocks interleukin 23 (IL-23), according to a news release.

Janssen reported that there was an expedited regulatory review of guselkumab after the application of an FDA priority review voucher.

Guselkumab is administered as a 100-mg subcutaneous injection every 8 weeks, with two starter doses at weeks 0 and 4.

“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 patients receiving this IL-23 specific therapy at week 16 and up to week 48,” researcher Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center, stated 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.”

Patients who received guselkumab experienced significant improvements in skin clearance and greater improvement in psoriasis symptoms, including itch, pain, stinging, burning and skin tightness when compared with placebo at week 16 in clinical studies, according to the release. Psoriasis Area and Severity Index (PASI) 90 was demonstrated in patients treated with guselkumab when compared to treatment with Humira (adalimumab, AbbVie) at weeks 16, 24 and 48.

A clinical development program of more than 2,000 patients in phase 3 studies was used in the FDA approval. Among study findings, seven of 10 patients achieved at least 90% clearer skin at week 16, with 80% achieving clear or almost clear skin. Nearly nine of 10 patients treated with guselkumab who achieved PASI 90 at week 28, maintained the response through week 48, according to the release.

Guselkumab may lower the ability to fight infections and may increase the risk of infections, according to the release. Patients should have a health care provider check them for infection and tuberculosis before beginning treatment.

Janssen reported that a study of guselkumab for treating active psoriatic arthritis is ongoing, while a phase 3 study measuring the efficacy of guselkumab vs. Cosentyx (secukinumab, Novartis) for treating moderate-to-severe plaque psoriasis is under way.

Reference: www.janssen.com