, /PRNewswire/ -- AbbVie (NYSE: ) today announced that it has submitted applications for a new indication to the U.S. 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 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 , 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 results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of upadacitinib in patients with GCA.
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. For more information regarding this study, please visit ClinicalTrials.
gov (Identifier NCT03725202). 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. 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. It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis. It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.
Tell your HCP if you: including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects. If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects. Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ.
Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP.
These are not all the possible side effects of RINVOQ. RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet.
Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food.
RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP.
Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ. Please click here for the and . 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. For more information, visit . 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.
We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and SOURCE AbbVie.
