AbbVie has submitted a marketing authorization application (MAA) for risankizumab, an interleukin 23 (IL-23) inhibitor, to the European Medicines Agency (EMA) with the intention of seeking approval for its use in moderate-to-severe plaque psoriasis.

In 2017, AbbVie reported that Humira (adalimumab), an anti-tumor necrosis factor (TNF) biologic indicated for multiple immunological disorders including psoriasis, generated sales of $18.42bn, accounting for 65% of AbbVie’s total net revenue. GlobalData believes that if approval is granted for risankizumab, AbbVie could further strengthen its position in the psoriasis market.

Risankizumab is an investigational compound that has been designed by AbbVie to selectively inhibit IL-23 by binding to its subunit, p19. AbbVie has evaluated risankizumab’s potential to deliver long-term skin clearance for psoriasis using a 12-week dosing. To support this application, results from four pivotal Phase III trials (ultIMMA-1, ultIMMa-2, IMMhance, and IMMvent) evaluating more than 2,000 patients with moderate-to-severe plaque psoriasis have been used.

These studies included an assessment of the efficacy, safety, and tolerability of risankizumab in moderate-to-severe psoriasis patients. In all four of the pivotal trials, the drug reached its primary endpoints. Results from the IMMhance study indicated that 73% of patients treated with risankizumab achieved a psoriasis area severity index (PASI) score of 90 at Week 16 compared to 2% of patients receiving placebo.

The currently approved IL-23 inhibitors for psoriasis include Johnson and Johnson’s Tremfya (guselkumab) and Sun Pharma’s Ilumya (tildrakizumab). Both Tremfya and Ilumya have been shown to have high efficacy in moderate-to-severe psoriasis. Tremfya showed that after 16 weeks of treatment in moderate-to-severe patients, 70% of patients achieved PASI 90, compared to 2% of the placebo-treated group. Additionally, in another Phase III study, Sun Pharma showed that 39% of patients treated with Ilumya achieved PASI 90 compared to 3% of patients treated with placebo. Although there are not yet any head-to-head trials comparing the efficacy of these drugs to one another, it is clear from Phase III trials that risankizumab and Tremfya will compete for best-in-class status, as both IL-23 drugs deliver high efficacy for moderate-to-severe psoriasis patients.

With the anticipated launch of Humira biosimilars in the EU starting from October 2018, AbbVie’s position is threatened in the psoriasis market by both biosimilar erosion and other major pharma companies gaining approval for their IL-17 and IL-23 biologics. This may not affect AbbVie immediately, since physicians will likely continue to prescribe Humira as one of their first-line biologic therapies for moderate-to-severe psoriatic patients. However, the less frequent dosing of IL-17 and IL-23 biologics could shift physicians to opt for these therapeutics eventually. Despite these challenges, AbbVie intends to remain a player within the changing field of psoriasis treatment. With the submission of an MAA for risankizumab, the company could be closer to retaining a strong position in the psoriasis space.

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