The approval comes as welcome news for AbbVie, which seeks to strengthen its immunology sales as it faces biosimilar competition for its flagship therapy, adalimumab (Humira).
AbbVie has received FDA approval for a novel biologic, risankizumab-rzaa (Skyrizi), an interleukin-23 inhibitor, for the treatment of plaque psoriasis.
The drug, at a dose of 150 mg, is administered by 2 subcutaneous injections every 12 weeks after initiation doses at week 0 and week 4.
Approval of the biologic was based on data from a global phase 3 psoriasis program. In the ultlMMA-1 and ultlMMA-2 pivotal studies, at 16 weeks, 75% of enrolled patients reached criteria for 90% skin clearance on the Psoriasis Area and Severity Index (PASI 90). PASI 100 was reached by 36% and 51% of patients in the 2 trials, respectively.
At 1 year, 82% and 81% of patients in the trials achieved PASI 90, and 56% and 60% reached PASI 100. An integrated analysis of the 2 trials showed that most patients (88% and 80%, respectively) who achieved PASI 90 or PASI 100 at week 16 maintained their response up to 1 year.
“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, MD, vice chairman and president of AbbVie, in a statement. “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 drug was also recently approved in Canada and Japan. AbbVie has also received a positive opinion for the therapy from the European Medicines Agency’s Committee for Medicinal Products for Human Use and anticipates European authorization for the drug shortly. Furthermore, risankizumab could see an expanded label in the future; phase 3 trials of the drug are underway in Crohn disease and psoriatic arthritis.
The approval comes as welcome news for AbbVie, which seeks to strengthen its immunology sales as it faces biosimilar competition for its flagship therapy, adalimumab (Humira). While sales of the brand-name Humira made up 61% of the company’s revenues in 2018, it has faced competition in the European Union from a host of biosimilars that began to reach the market in October 2018.
In earnings results announced today, AbbVie said that the brand-name adalimumab saw its net international revenues drop to $1.231 billion during the first quarter, a decrease of 27.9% on a reported basis, which the company says was a result of biosimilar competition. US Humira revenue grew by 7.1% last quarter to $2.315 billion, as the company still faces no US biosimilar competitors, but worldwide net revenues for Humira dropped by 5.6% on a reported basis.