The US Food and Drug Administration (FDA) has granted approval for Janssen Biotech’s Tremfya (guselkumab) to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Patients following systemic therapy may benefit from taking injections or pills, while the ones undergoing phototherapy receive treatment using ultraviolet (UV) light.
Tremfya is currently the first and only approved biologic therapy and a human monoclonal antibody that selectively blocks the protein interleukin (IL)-23, a cytokine that plays a major role in plaque psoriasis.
The Janssen therapy is administered every eight weeks as a 100mg subcutaneous injection, following two starter doses at weeks 0 and 4.
During clinical studies, patients receiving the treatment demonstrated significant improvement in skin clearance, as well as in symptoms of plaque psoriasis, including itch, pain, stinging, burning and skin tightness when compared with placebo at week 16.
The approval is based on results from Phase III VOYAGE 1, VOYAGE 2 and NAVIGATE trials that involved more than 2,000 patients.
The VOYAGE 1 and VOYAGE 2 trials demonstrated significant efficacy in patients with moderate-to-severe plaque psoriasis when treated with Tremfya.
The findings from NAVIGATE highlighted the effectiveness of the therapy in patients who had an inadequate response to treatment with Stelara (ustekinumab).
Janssen Biotech medical affairs vice-president Dr Andrew Greenspan said: “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.
“Considering this, we applied a priority review voucher to the application for Tremfya to bring this novel treatment to patients sooner.”