AbbVie Seeks US FDA & EMA Approvals for Upadacitinib to Treat Adult with Giant Cell Arteritis

AbbVie Seeks US FDA & EMA Approvals for Upadacitinib to Treat Adult with Giant Cell Arteritis

By, Admin 16 July 2024

Overview

AbbVie announced 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; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).

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.

Words from CSO: AbbVie

  • 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 3 study evaluating the safety and efficacy of upadacitinib in patients with GCA.

SELECT-GCA Study

  • SELECT-GCA (M16-852) is a phase 3, 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.

About Giant Cell Arteritis

  • Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries. 
  • GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision. Caucasian women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing giant cell arteritis. 
  • Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.

About Rinvoq

  • Discovered and developed by AbbVie scientists, Rinvoq is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. 
  • Based on enzymatic and cellular assays, Rinvoq demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.
  • The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. 
  • Upadacitinib (Rinvoq) is being studied in phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. 
  • The use of upadacitinib in giant cell arteritis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

AbbVie for Rheumatic Diseases

  • For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. 
  • Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

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