AbbVie has shared new efficacy and safety data for Rinvoq (upadacitinib) in adults and adolescents with atopic dermatitis (AD) from a trio of ongoing phase 3 studies. Spanning 140 weeks, these studies sustained the co-primary endpoints of Eczema Area and Severity Index 75 (EASI 75) and validated Investigator’s Global Assessment for Atopic Dermatitis 0/1 (vIGA-AD…
FDA approves AbbVie’s Rinvoq for nr-axSpA
FDA has approved AbbVie’s Rinvoq (upadacitinib) for adults with active non-radiographic axial spondyloarthritis (nr-axSpA). The indication covers nr-axSpA patients with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors. The JAK1 selective inhibitor Rinvoq now has six U.S. indications. The new indication makes Rinvoq the only…
AbbVie’s Rinvoq supports clinical remission in Phase 3 Crohn’s disease study
AbbVie (NYSE:ABBV) has revealed positive topline results from the U-ENDURE Phase 3 study investigating 15- and 30-mg doses of Rinvoq (upadacitinib) in adults with moderate to severe Crohn’s disease. Recipients who received either dose met the co-primary endpoints of endoscopic response and clinical remission, AbbVie announced. More than one-third (36%) of participants who received 15…
FDA approves AbbVie’s Rinvoq for active ankylosing spondylitis
AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine. The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis. The ankylosing spondylitis indication is limited to…
FDA grants Rinvoq new indication for moderate to severe atopic dermatitis
FDA has approved Rinvoq (upadacitinib) from AbbVie (NYSE:ABBV) to treat moderate to severe atopic dermatitis in individuals at least 12 years old. AbbVie anticipates 2025 risk-adjusted sales for Rinvoq to top $7.5 billion. The most common type of eczema, atopic dermatitis, can be managed with various therapies, including corticosteroids, topical calcineurin inhibitors and immunosuppressants. Nevertheless, the…
AbbVie files Rinvoq application for non-radiographic axial spondyloarthritis in U.S. and Europe
AbbVie (NYSE:ABBV) has submitted applications asking for approval of upadacitinib (Rinvoq) from the FDA and the European Medicines Agency (EMA) to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA). If approved, Rinvoq would be indicated for nr-axSpA patients with objective signs of inflammation with an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). The Janus kinase…
Rinvoq meets primary and important secondary endpoints in Phase 3 Crohn’s disease study
AbbVie (NYSE:ABBV) has released positive top-line results from U-EXCEED, which showed that Rinvoq (upadacitinib) hit both primary endpoints of clinical remission and endoscopic response at week 12 of a Phase 3 induction study focused on patients with Crohn’s disease. Upadacitinib is a selective and reversible JAK inhibitor first FDA approved in 2019 for treating adults with…
AbbVie shares new Rinvoq data involving patients with psoriatic arthritis
Abbvie’s (NYSE:ABBV) JAK inhibitor Rinvoq (upadacitinib) beat out placebo at week 24 in posthoc analyses of two Phase 3 studies focused on people with active psoriatic arthritis. In particular, the drug led to a superior clinical response related to axial involvement, which occurs in a substantial portion of people with psoriatic arthritis. Sharing the data…
AbbVie’s Rinvoq met primary endpoint in ankylosing spondylitis trial
AbbVie (NYSE:ABBV) has announced positive top-line results in a Phase 3 trial focusing on patients with active ankylosing spondylitis (AS), an inflammatory disease that can eventually lead to fused vertebrae. The first of two studies, the SELECT-AXIS 2 study examined a daily 15-mg dose of Rinvoq (upadacitinib) in AS patients who had an inadequate response…
34 of the most innovative pharmaceutical products
The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…
Rinvoq could hold promise for atopic dermatitis
The Janus kinase (JAK) inhibitor Rinvoq (upadacitinib) from AbbVie has a current indication for moderate to severe active rheumatoid arthritis for patients with an inadequate response or intolerance to the immunosuppressant methotrexate. Rinvoq is seeking expanded approval for the drug to treat moderate to severe atopic dermatitis (AD), which is a form of eczema. Earlier this…