European Commission Approves Risankizumab for Pediatric Psoriasis Treatment in Children Above Six

AbbVie Receives European Commission Approval for Risankizumab

AbbVie, a pharmaceutical leader based in North Chicago, Illinois, is proud to announce that it has received approval from the European Commission (EC) for its drug Risankizumab. This medication is intended for pediatric patients aged six years and older who suffer from moderate to severe plaque psoriasis and are eligible for systemic therapy. This approval marks a significant milestone in expanding treatment options for young patients battling this chronic condition.

In addition to the overall approval, AbbVie has also secured the use of a new 55mg prefilled syringe designed for patients weighing less than 40 kg. This latest development aligns with the clinical advancements demonstrated in pivotal Phase 3 trials known as OptIMMize-1 and OptIMMize-2.

The Need for Effective Treatment Options

Psoriasis is often a distressing condition, with approximately one-third of psoriasis patients experiencing its onset before they reach the age of 18. In many cases, lesions develop in prominent areas of the body, such as the face and scalp, which poses a risk of psychological distress, social stigma, and potential complications due to missed school attendance. It is alarming to note that around 70% of young psoriasis patients lack effective treatment options beyond topical therapies.

Roopal Thakkar, M.D., Executive Vice President and Chief Scientific Officer at AbbVie, highlighted the complexities associated with pediatric psoriasis. “The approval of Risankizumab today is a meaningful step for millions of young patients worldwide who are seeking better treatment alternatives for this chronic disease,” Thakkar stated. He added that increasing the number of effective options for these patients is a pressing obligation.

Clinical Validation of Risankizumab

The basis for the EC approval of Risankizumab was rooted in robust clinical data gathered from two pivotal Phase 3 trials involving pediatric patients with moderate to severe psoriasis. The data encompassed randomized, efficacy-assessor blinded, and active-controlled cohorts from the OptIMMize-1 trial covering ages twelve to under eighteen, alongside a single-group, open-label cohort for those aged six to twelve. Furthermore, additional evidence was derived from the non-blinded continuation study, OptIMMize-2.

The safety profile of Risankizumab when administered to pediatric patients (137 cases) has been found to parallel that of adult patients suffering from moderate to severe psoriasis, showing no new safety signals, thus endorsing its safe application across age groups.

Insights from Dermatology Experts

Dr. Nina Magnolo, the lead investigator at the University Hospital of Münster's Dermatology Department, expressed her optimism regarding this development. “For pediatric psoriasis patients, early diagnosis and intervention can effectively prevent symptom exacerbation and improve quality of life in the long term. The EC approval for Risankizumab, particularly with the introduction of weight-based dosing, provides young patients with more treatment options that healthcare providers can confidently offer to fulfill unmet clinical needs,” said Dr. Magnolo.

Understanding Risankizumab

Risankizumab functions as an IL-23 inhibitor, specifically binding to the p19 subunit of Interleukin-23, thereby selectively blocking its effects. Understanding its mechanism reveals that IL-23 is implicated in various chronic immune-mediated inflammatory diseases, and its inhibition represents a promising therapeutic pathway. Risankizumab has successfully gained approval from both the U.S. Food and Drug Administration and the European Medicines Agency for conditions including moderate to severe plaque psoriasis and psoriatic arthritis, as well as Crohn's disease and ulcerative colitis in adult patients.

AbbVie’s Commitment to Immunology

AbbVie remains committed to addressing the challenges posed by immune-mediated inflammatory diseases. Through innovative scientific research and robust drug development, AbbVie is continuously seeking to redefine treatment standards for patients afflicted by these conditions. With over twenty years of pioneering research, AbbVie is invested in expanding its differentiated pipeline aimed at offering groundbreaking treatment options that effectively confront the complex biological underpinnings of immune-mediated conditions.

AbbVie's immunity treatments are now approved in over 175 countries, successfully reaching more than one million patients suffering from 19 different immune-mediated inflammatory diseases globally. As AbbVie strives to bolster its legacy of success, it remains focused on enhancing patient access to its transformative therapies.

For more information, visit AbbVie Immunology.

Conclusion

AbbVie’s recent accomplishments underscore its commitment to advocacy and innovation in the realm of immunology. The European Commission’s endorsement of Risankizumab not only highlights advancements in treatment but also strengthens the foundation for continued research and patient support in the fight against chronic inflammatory diseases, particularly among vulnerable pediatric populations.