Johnson & Johnson’s (J&J) Tremfya (guselkumab) has recently been granted approval for the treatment of adults suffering from moderate-to-severe plaque psoriasis in Australia, Brazil, and Japan. J&J has licensed Tremfya to MorphoSys in these respective regions.

Tremfya is the first fully human monoclonal antibody that binds specifically to interleukin 23 (IL-23), which is a crucial cytokine that induces the inflammatory processes in psoriasis. Tremfya was first approved in the US in July 2017 and then in the EU in November 2017 for the treatment of moderate-to-severe plaque psoriasis. GlobalData believes that with an increased number of regions approving this drug, sales of Tremfya will boost J&J’s competitiveness in the current psoriasis market.

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Tremfya received approval based on results from two 48-week, pivotal Phase 3 studies: VOYAGE 1 and VOYAGE 2. Both studies showed significant efficacy in adult patients with moderate-to-severe plaque psoriasis who were treated with Tremfya. In particular, the VOYAGE 1 study showed that Tremfya was superior to Abbvie’s Humira (adalimumab), with a significantly higher Psoriasis severity index 90 (PASI 90) score at 48 weeks (84% versus 53%) (P < 0.001).

Alternative approved biologics

Other recently approved biologics that could compete with Tremfya include the IL-17 inhibitors, Novartis’s Cosentyx (secukinumab), Eli Lily’s Taltz (ixekizumab), and Valeant’s Siliq (brodalumab), all of which are approved globally. Since Cosentyx and Taltz are also approved for use in Brazil, Japan, and Australia, Tremfya could now impact the sales of these drugs in these respective regions. Additionally, in the US, Tremfya will also compete with Sun Pharmaceuticals’ Ilumya (tildrakizumab), an anti-IL-23 that was granted FDA approval in March 2018 and poses a strong threat to J&J’s drug.

Ilumya is administered every 12 weeks, compared to Tremfya, which is administered every eight weeks after the initial treatment. This could threaten J&J’s position in the market, as fewer doses of Ilumya are required to treat patients compared to Tremfya. However, Tremfya holds first-to-market advantage and therefore has the potential to treat a greater number of patients. In addition to Ilumya, AbbVie is developing an anti-IL-23 drug, risankizumab, which is undergoing a Phase III trial for plaque psoriasis.

J&J already has global approval of Stelara (ustekinumab), an anti-IL-12/23 used to treat moderate-to-severe psoriatic patients. As Stelara and Tremfya are available globally, GlobalData expects that J&J could capture more of the psoriasis market. Additionally, Tremfya is in Phase III trials for psoriatic arthritis, and J&J have announced further plans to investigate Tremfya in autoimmune diseases such as Crohn’s disease. If approved in these indications, Tremfya could further J&J’s sales potential in the immunology space.

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