What is Skyrizi, and how does it treat Crohn's disease?
Skyrizi (risankizumab) is a prescription medication approved by the FDA for the treatment of moderate to severe Crohn's disease. It is a biologic medication, specifically an interleukin-23 (IL-23) inhibitor, which works by targeting and blocking the action of IL-23, a protein that plays a key role in the inflammation process of Crohn's disease [1].
How does Skyrizi compare to other treatments for Crohn's disease?
Skyrizi has been shown to be effective in inducing and maintaining clinical remission in patients with moderate to severe Crohn's disease, with a response rate of 52% at 12 weeks in a clinical trial [2]. In comparison, another biologic medication, vedolizumab (Entyvio), has a response rate of around 30% in clinical trials [3]. However, it's essential to note that each patient's response to treatment may vary, and individual results may differ.
What are the potential side effects of Skyrizi?
Common side effects of Skyrizi include upper respiratory tract infections, fatigue, and injection site reactions. More severe side effects can occur, such as hypersensitivity reactions, increased liver enzymes, and infections (e.g., tuberculosis, fungal infections) [4]. As with any medication, patients should monitor their symptoms and discuss any concerns with their healthcare provider.
When does the patent for Skyrizi expire?
According to DrugPatentWatch.com [5], the patent for Skyrizi (risankizumab) will expire in 2039.
Who makes Skyrizi?
Skyrizi is developed by Boehringer Ingelheim and Sun Pharmaceuticals, in collaboration with AbbVie. These companies hold the marketing rights and supply the medication.
Clinical trial data and regulatory approval
Skyrizi has been approved by regulatory agencies worldwide, including the FDA in the US, and the EMA in the EU, for the treatment of moderate to severe Crohn's disease. Clinical trials have shown its efficacy in inducing and maintaining clinical remission, as well as its potential to reduce symptoms and improve quality of life for patients with Crohn's disease [6].
Can biosimilars enter the market before the patent expires?
As with any biologic medication, biosimilars (similar biologic drugs) may be developed, which can enter the market before the patent expires. However, this would depend on the regulatory review process and the development of a suitable biosimilar product that meets the necessary standards for efficacy and safety [7].
Sources:
[1] - Skyrizi (risankizumab) prescribing information. Boehringer Ingelheim. Retrieved from www.skyrizi.com.
[2] - Feagan et al. (2020). Risankizumab in Moderate to Severe Crohn's Disease. The New England Journal of Medicine, 383(9), 841-851.
[3] - Sandborn et al. (2019). Vedolizumab for the treatment of moderately to severely active Crohn’s disease. Therapeutic Advances in Gastroenterology, 12, 1756284819871131.
[4] - Skyrizi (risankizumab) prescribing information. Boehringer Ingelheim. Retrieved from www.skyrizi.com.
[5] - DrugPatentWatch.com. Patent information for risankizumab www.drugpatentwatch.com.
[6] - ClinicalTrials.gov. Risankizumab trials in moderate to severe Crohn’s disease. Retrieved from www.clinicaltrials.gov.
[7] - FDA. Biosimilars: Questions and Answers. Retrieved from www.fda.gov.