Regulatory applications submitted to FDA and EMA for upadacitinib (Rinvoq) in Giant Cell Arteritis.- AbbVie
AbbVie announced that it has submitted applications for a new indication to the FDA and European Medicines Agency (EMA) for upadacitinib (Rinvoq; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).
GCA is an autoimmune disease of medium and large arteries and can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision.
"Currently, there are few approved treatment options for patients with GCA. Most patients are managed with glucocorticoids, and many are unable to discontinue them without the recurrence of GCA symptoms," stated Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer, AbbVie. "We recognize the importance of maintaining remission and limiting the use of glucocorticoids in GCA."
The regulatory submissions to the FDA and EMA are supported by previously announced results from the SELECT-GCA Phase III study evaluating the safety and efficacy of upadacitinib in patients with GCA.
About SELECT-GCA : SELECT-GCA (M16-852) is a Phase III, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consists of two periods. The first period evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the first period assessed the safety and tolerability of upadacitinib in these patients. The second period is ongoing to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period. For more information regarding this study, please visit ClinicalTrials.gov (Identifier NCT03725202).
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