FDA Approves Tremfya for Moderate to Severe Plaque Psoriasis

First and only biologic approved that selectively blocks interleukin-23.

The FDA has approved guselkumab (Tremfya, Janssen Biotech) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the first approved biologic therapy that selectively blocks only interleukin (IL)-23, a cytokine that plays a key role in plaque psoriasis.

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 adalimumab (Humira, AbbVie) at weeks 16, 24, and 48.

Approval comes after an expedited regulatory review following application of an FDA priority review voucher. Tremfya received the 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.

In clinical studies, at 16 weeks, at least seven out of 10 Tremfya-treated patients achieved at least 90% clearer skin, and more than 80% 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. 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% clearer skin compared with more than four out of 10 patients treated with Humira.

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

Janssen said it 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.

Source: Janssen Biotech, Inc.; July 13, 2017.