AbbVie Submits Regulatory Applications for IL-23 Inhibitor Skyrizi® (risankizumab) in Psoriatic Arthritis to FDA and EMA
Apr 08, 2021 01:49
CST Updated
01:49
AbbVie
Innovative Drug Developer
FDA
U.S. Food and Drug Administration
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
April 07, 2021 /Bio ValleyBIOON/ -- AbbVie recently announced that it has submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication of the novel anti-inflammatory drug IL-23 inhibitor Skyrizi (risankizumab, 150 mg) for the treatment of adult patients with active psoriatic arthritis (PsA).
Psoriatic arthritis (PsA) is a systemic inflammatory disease affecting the skin and joints, impacting approximately 30% of patients with psoriasis. In pivotal Phase 3 studies, patients treated with Skyrizi received four maintenance doses annually after two initial doses. Compared with placebo, Skyrizi significantly improved skin and joint symptoms and physical function, with a higher proportion of patients achieving minimal disease activity.
Michael Severino, M.D., Vice Chairman and President of AbbVie, stated, “Most patients with psoriatic arthritis experience both skin and joint manifestations, which can impose a particularly heavy burden. Despite advances, many patients fail to achieve relief from the signs and symptoms of this disease. We are committed to delivering new treatment options to help patients meet their therapeutic goals.”
Psoriatic Arthritis - PsA (Image source: rheumatologyadvisor.com)
This new indication application is based on data from two pivotal Phase 3 clinical studies (KEEPsAKE-1 and KEEPsAKE-2). These two studies were conducted in adult patients with active psoriatic arthritis (PsA), including those who had an inadequate response to or were intolerant of biologic and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).
The results showed that, compared with the placebo group, a significantly higher proportion of patients in the Skyrizi (150 mg) treatment group achieved the primary endpoint of an ACR20 response at Week 24: in the two studies, 57% and 51% of patients in the Skyrizi group achieved an ACR20 response at Week 24, versus 34% and 27% in the placebo groups, respectively (p < 0.001).
Secondary Endpoints: At Week 24 of treatment, the Skyrizi group demonstrated significant improvements compared with the placebo group in skin clearance (as measured by at least a 90% improvement in the Psoriasis Area and Severity Index [PASI 90]), physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]), and minimal disease activity (MDA).
In the KEEPsAKE-1 study, the PsA Sharp/van der Heijde score (PsA mTSS) at Week 24, a secondary endpoint, was 0.23 in the Skyrizi group and 0.32 in the placebo group (p=0.496 [Note: A lower score indicates slower radiographic progression]).
In these two studies, the safety profile of Skyrizi was generally consistent with that observed in the treatment of plaque psoriasis, and no new safety risks were identified.
The active pharmaceutical ingredient of Skyrizi is risankizumab, a monoclonal antibody that selectively blocks interleukin-23 (IL-23), an immune inflammatory mediator in the body, by specifically targeting the IL-23p19 subunit. IL-23 is a cytokine believed to play a key role in many chronic immune-mediated diseases. Risankizumab was originally developed by the German pharmaceutical company Boehringer Ingelheim (BI). In February 2016, AbbVie acquired the global commercialization rights to risankizumab through an upfront payment of $600 million.
In 2019, Skyrizi was approved in the United States and the European Union for the treatment of adult patients with moderate-to-severe plaque psoriasis. Currently, Skyrizi is in Phase III clinical trials for the treatment of Crohn's disease and psoriatic arthritis. Additionally, AbbVie is also evaluating Skyrizi for the treatment of other inflammatory conditions, such as ulcerative colitis.ImmunologyDisease.
Skyrizi is entering a highly crowded market, where it will compete with multiple drugs, including:NovartisCosentyx and Ilaris,Eli Lillysuch as Eli Lilly’s Taltz, Valeant’s Siliq, Johnson & Johnson’s Tremfya, and Sun Pharma’s Ilumya. Among these drugs, Tremfya and Ilumya are also biologic therapies that selectively target IL-23.
Nevertheless, despite facing all these competitors, Skyrizi has demonstrated robust sales performance, with global sales reaching $1.59 billion in 2020, representing a year-over-year growth of over 100%. Following the success of a series of Phase III clinical trials, AbbVie optimistically projects that combined sales of Skyrizi and Rinvoq, another oral anti-inflammatory JAK inhibitor, will reach $15 billion by 2025. This revenue is expected to offset the sales losses incurred by its flagship product, Humira (adalimumab), in the U.S. market due to competition from biosimilars starting in 2023. (Bioon.com)