The European Commission has approved AbbVie’s new blockbuster-in-waiting psoriasis treatment Skyrizi (risankizumab), just one week after it gained US approval.
The drug has been approved for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy, and is a vitally important new approval for AbbVie, which is already seeing the rapid erosion of blockbuster Humira in Europe due to biosimilar competition.
Skyrizi, which is co-developed and co-marketed with Boehringer Ingelheim will be launched in the US in the coming weeks and will carry a list price of $59,000, though this will be heavily discounted, with European markets certain to enjoy lower prices.
AbbVie has previously forecast Skyrizi’s revenues to reach $5 bn by 2023, though analysts at Clarivate predict a much more modest $1.73bn by this date.
Much of its commercial success will depend on how rapidly it can additional indications to its roster, and how it fares in the market place and in head-to-head trials against a number of key competitors.
Skyrizi is entering a crowded field, and AbbVie has armed it with some strong head-to-head studies with existing treatments. Two studies compared risankizumab to J&J’s $4bn-a-year IL-12/IL-23 inhibitor Stelara (ustekinumab) and one against its own TNF inhibitor Humira (adalimumab), currently the biggest-selling drug in the world with revenues of nearly $20bn in 2018.
The analysis showed that 56% of patients on risankizumab were symptom-free after a year’s treatment, compared to 30% of the Stelara group.
The drug is already in trials for psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Skyrizi (150 mg) is approved for administration via two subcutaneous injections every 12 weeks following two initiation doses.
“This approval is an important step forward in providing people living with moderate to severe psoriasis with a new treatment option,” said Michael Severino, M.D., vice chairman and president, AbbVie.
“The results seen in our clinical studies, including high levels of complete skin clearance with 12-week dosing and a favourable safety profile, suggest Skyrizi has the potential to provide long-term relief from the signs and symptoms of psoriasis. We are proud to expand our portfolio of treatment options for people living with this condition in Europe.”
The drug received EC approval based on four pivotal phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.1-4 Across all four studies, the co-primary endpoints were at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at week 16.1-4
AbbVie is also hoping for approval of another tipped immunology blockbuster upadacitinib, which was accepted by the FDA two months ago under its priority review scheme.
The EU approval for the drug, just one week after the FDA’s green light is unusual, with Europe frequently having to wait six months or more to follow the US.