The EMA’s key medicines committee the CHMP has recommended AbbVie and Boehringer Ingelheim’s Skyrizi (risankizumab), setting up the new psoriasis drug for approval in the next few months.
Skyrizi is one of the new class of interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Analysts have marked out the drug as a potential best-in-class in the therapy area thanks to strong results in a three-way head-to-head comparing it with Johnson & Johnson’s Stelara (targeting IL-23 and IL-12) and AbbVie’s own ageing market leader Humira.
Analysts forecast peak sales for Skyrizi to be $2.3bn worldwide and the CHMP recommendation is an important step towards its market entry.
In the US, the drug has an FDA decision date (PDUFA) of 25 April.
The CHMP positive opinion is supported by data from the global Phase 3 psoriasis programme evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase 3 studies.
Across all four studies, ultIMMA-1, ultIMMa-2, IMMhance and IMMvent, all co-primary and ranked secondary endpoints were met, achieving a significantly higher response of clear or almost clear skin (Static Physicians Global Assessment [sPGA] 0/1 and Psoriasis Area and Severity Index [PASI] 90) compared to Stelara and Humira and placebo at week 16 and up to week 52 (depending on study design).
Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialisation of the drug globally.
Confident of the drug’s best-in-class status, AbbVie also have underway a head-to-head study with the emerging market leader in the sector, Novartis’ Cosentyx, with this trial due to reach completion in June 2020.
Risankizumab is also being in clinical trials for a number of other inflammatory diseases, including Crohn’s disease, ulcerative colitis, atopic dermatitis and psoriatic arthritis.
The launch of Skyrizi in Europe is especially important for AbbVie as Humira is already losing revenue rapidly in the continent thanks to the arrival late last year of biosimilars.
Full year global sales of Humira rose 7.4% to just shy of $20bn, but Q4 figures showed that non-US revenues declined sharply by 17.5%, reflecting a rapid uptake of cheaper biosimilars in the region.
AbbVie has another inflammation treatment nearing the market, upadacitinib, which is being studied in atopic dermatitis (eczema) and rheumatoid arthritis.