FDA Approves Tremfya (guselkumab) for Plaque Psoriasis Save

The U.S. Food and Drug Administration (FDA) has approved the IL-23 inhibitor, Tremfya (guselkumab), for patients with moderate to severe plaque psoriasis.

The drug received an expedited regulatory review following application of an FDA Priority Review Voucher.

After loading doses at weeks 0 and 4, guselkumab is given as 100 mg subcutaneously (prefilled syringe) every eight weeks. 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.

The clinical development program included more than 2,000 patients in the Phase 3 VOYAGE 1, VOYAGE 2 and NAVIGATE studies, which have been previously presented or published in peer-reviewed journals. In a head-to-head trial, guselkumab beat adalimumab (ADA) with PASI90 results of 73% compted to 2.9% on placebo and 50% percent on ADA.

The NAVIGATE study tested the effectiveness of Tremfya in patients who had an inadequate response to ustekinumab and found 28-31% of Tremfya-treated patients were considered cleared or almost cleared versus 14% of UST treated patients at 12 weeks.

There are no contraindications or boxed warnings. Most common (≥1%) adverse reactions associated with Tremfya include upper respiratory infections, headache, injection site reactions, arthralgia,diarrhea, gastroenteritis, tinea infections, and herpes simplex infections. Elevated hepatic enzymeswere reported more frequently in the Tremfya group (2.6%) than in the placebo patients (1.9%). 

Guselkumab has been shown to be ineffective in rheumatoid arthritis, and is currently under study in psoriatic arthritis and ankylosing spondylitis. 

The addition of Tremfya will crowd a growing market for psoriatic therapies and will compete with existing approve therapies including the TNF inhibitiors, the IL-17 inhibitors (secukinumab, ixekizumab) and apremilast. Next month, the FDA will convene a hearing over the application to approve tofacitinib for psoriatic arthritis.