#USA #AbbVie #North Chicago #RINVOQ #Vitiligo

AbbVie Seeks Regulatory Approval for Upadacitinib (RINVOQ®)

AbbVie, a global biopharmaceutical company based in North Chicago, has taken a significant step by submitting applications for their drug, upadacitinib (marketed as RINVOQ®), to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This application specifically aims to provide a new treatment option for adult and adolescent patients diagnosed with non-segmental vitiligo (NSV), a chronic and often distressing autoimmune skin condition.

Vitiligo affects approximately 84% of patients with this condition and is characterized by the appearance of depigmented patches on the skin, which may rise unpredictably even after extended periods of stability. The implications of vitiligo extend beyond mere skin depigmentation; it poses a significant psychosocial burden, impacting individuals' confidence and daily life considerably. Current management strategies primarily aim for disease stabilization and re-pigmentation, goals that remain unmet for many patients given the absence of approved systemic therapies.

The regulatory submissions from AbbVie hinge on promising results obtained from the Phase 3 Viti-Up clinical studies, which explored the efficacy and safety of upadacitinib. In the trials, the treatment achieved its co-primary endpoints with notable improvements in total body repigmentation, defined by at least a 50% reduction in the Total Vitiligo Area Scoring Index (T-VASI 50) and at least a 75% improvement in facial repigmentation through the Facial Vitiligo Area Scoring Index (F-VASI 75) within just 48 weeks. These endpoints highlight the treatment's potential to deliver significant aesthetic and psychological relief for those afflicted by vitiligo, especially in visible areas such as the face.

Dr. Kori Wallace, the Vice President and Global Head of Immunology Clinical Development at AbbVie, commented on the pressing need for systemic treatment options, highlighting patient frustrations regarding the unpredictable nature of NSV spread and the lack of effective therapies. "The Viti-Up clinical studies explored these treatment gaps in vitiligo care and reinforced AbbVie’s commitment to providing the first systemic treatment for patients, aiming to change the landscape of vitiligo treatment," Dr. Wallace stated.

The Viti-Up clinical studies were comprehensive, involving two replicate Phase 3 trials with a total of 614 participants randomized across 90 sites globally. Each participant received either RINVOQ (15 mg) or a placebo for a period of 48 weeks, after which all continued with the treatment in an open-label extension phase. The meticulous study design and robust findings support the submission and the anticipated transformative impact of the drug on the treatment of vitiligo.

Vitiligo’s treatment history has been limited due to the system's inability to deliver effective results consistently. RINVOQ, a Janus kinase (JAK) inhibitor, is being researched for a variety of autoimmune and inflammatory conditions. If approved, upadacitinib will not only represent a significant advancement in the management of vitiligo but will also fulfill an essential need for patients who currently feel underserved by existing treatment options.

As AbbVie awaits the FDA and EMA's decisions, the med-tech and dermatological communities, alongside patient advocates, are keenly watching developments in the vitiligo treatment paradigm. This potential for a new systemic agent in managing vitiligo could markedly enhance quality of life and provide hope for those grappling with the profound effects of this challenging condition.