Following similar decisions by authorities in Japan and Canada, the US Food and Drug Administration (FDA) approved Skyrizi (risankizumab), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis.
In clinical trials, the monoclonal antibody (mAb) achieved 90% skin clearance in 81% of patients, which compares favourably to results seen in clinical trials for Humira (adalimumab).
The treatment is delivered by two subcutaneous injections every 12 weeks, which can be administered in an office setting or by self-injection after training.
Michael Severino, vice chairman and president of AbbVie, said, “Skyrizi builds on AbbVie's legacy in immunology, expanding our portfolio to help meet the evolving needs in psoriatic disease and reinforcing our continued pursuit of innovations that improve care for people living with immune-mediated conditions.”
Continuing the legacy
AbbVie’s ‘legacy’ is the dominance of the autoimmune disease market by Humira, which brought in $19.9bn (€17.75bn) of revenue in full-year 2018 results.
However, Humira is already facing biosimilar competition in Europe and its key market, the US, will also see the entry of competitors from 2023.
By comparison, Evaluate estimates that Skyrizi will not bring in the same amount of revenue, with projections of an earnings potential of just over $2bn by 2024.
In addition, Skyrizi will enter a crowded market, with a number of anti-IL-23 and anti-IL-17 treatments on the market – including Novartis’ Cosentyx (secukinumab), which the company just revealed experienced growth of 41% in the first quarter of this year, and Eli Lilly’s Taltz (ixekizumab).
AbbVie is waiting on the final decision from the European Commission for approval in the same indication, but previously received a positive opinion from the European Medicines Agency’s Committee for Medical Products for Human Use in March 2019.
AbbVie paid Boehringer Ingelheim $595m as an initial upfront fee to license the treatment, gaining development and exclusive commercialisation rights in 2016.
