AbbVie (NYSE: ABBV), a United States-based pharmaceutical company, announced on Friday that it has submitted applications for a new indication to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ(R); 15mg, once daily) intended to treat adult patients with giant cell arteritis (GCA).

The company submitted application to the FDA and EMA based on earlier announced results from the SELECT-GCA Phase three study assessing the safety and efficacy of upadacitinib in subjects with GCA.

SELECT-GCA (M16-852), a Phase three, multicentre, randomised, double-blind placebo-controlled study, is aimed at assessing the safety and efficacy of upadacitinib in 428 subjects with GCA. The study includes two periods. The first assessed the efficacy of the product along with a 26-week corticosteroid taper regimen compared to placebo along with a 52-week corticosteroid taper regimen, and also evaluated the safety and tolerability of the product. The second period is ongoing to assess the safety and efficacy of continuing compared to withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period.

Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer, AbbVie, said, '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. We recognise the importance of maintaining remission and limiting the use of glucocorticoids in GCA.'