AbbVie has bagged US approval for Skyrizi – a treatment for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The IL-23 inhibitor is expected to reach blockbuster sales, with analysts such as Clarivate Analytics predict the drug making $1.74bn in 2023 for AbbVie and its partner Boehringer Ingelheim, who originally developed the drug.
The FDA cleared the drug based on the results from two clinical trial programmes – ultlMMa-1 and ultlMMa-2 – and 82% and 81% of those treated with Skyrizi achieved 90% of skin clearance in accordance with the Psoriasis Area and Severity Index(PASI) score one year on.
The majority (56% and 60%) also achieved complete skin clearance, in line with PASI, at one year.
“The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals,” said Kenneth Gordon, a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin.
“In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I’m pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response.”
The drug is expected to be available next month, and is administered (either in -office or by self injection) by two subcutaneous injections every 12 weeks.
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 $16bn in 2017. 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 approval of Skyrizi is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time,” said Michael Severino, vice chairman and president, AbbVie.
“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.”
The approval builds on AbbVie’s immunology profile, which is a key area for the drug maker to focus on as its megablockbuster Humira faces biosimilar competition.
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.
That JAK1-selective inhibitor is intended to treat those with immune-meditated disease, including rheumatoid arthritis (RA), a therapy area where the drug has so far aced all of its clinical trials.
AbbVie has also submitted the drug to the European Medicines Agency back in December, with an approval likely after the CHMP gave a positive recommendation to the drug last month.