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 JAK inhibitor approved for adults with nr-axSpA.

To win the latest indication, Abbott submitted data from the Phase 3 SELECT-AXIS 2 clinical study focusing on adults with active nr-axSpA. The placebo-controlled study found that almost half of the recipients of Rinvoq 15 mg had achieved at least 40% improvement based on the Assessment in SpondyloArthritis International Society scale (ASAS40) at week 14. ASAS40 was the primary endpoint. 

The safety profile of Rinvoq was similar in the nr-axSpA demographic to earlier Rinvoq trials involving patie…

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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 mg of upadacitinib achieved clinical remission at week 52. A total of 46% of those receiving the 30-mg dose achieved the same benchmark, compared with 14% of placebo recipients.

Subjects also achieved the secondary endpoint of endoscopic remission at 52 weeks compared to placebo.

Study participants were poor candidates for conventional or biologic therapy.

The study defined clinical remission using the Crohn’s Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).

Rinvoq first won FDA approval in 2019 for rheumatoid ar…

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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 patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) inhibitors.

AbbVie provided data from two pivotal studies showing the drug supported The Assessment in SpondyloArthritis international Society 40% (ASAS40) benchmark to win the latest indication.

Rinvoq image courtesy of AbbVie

ASAS40 refers to an at least 40% improvement in three out of four domains related to back pain, disease activity, physical function and inflammation. The ASAS40 respons…

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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 (JAK) inhibitor Rinvoq recently won FDA approval for an active psoriatic arthritis indication.

FDA first approved Rinvoq for moderate to severe rheumatoid arthritis in 2019.

For the potential nr-axSpA indication, AbbVie filed positive data from the Phase 3 SELECT-AXIS 2 study.

“Axial spondyloarthritis is a chronic inflammatory disease affecting the spine and can cause patients, who tend to be younger adults living active lives, to suffer from debilitating pain and significantly decrease their quality of life,” said Dr. Thomas…

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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 moderate to severe rheumatoid arthritis. It is now also marketed for ankylosing spondylitis and psoriatic arthritis.

The U-EXCEED is the first of two Phase 3 induction studies testing upadacitinib in adults with moderate to severe Crohn’s disease.

The multicenter study was randomized, double-blind and placebo-controlled.

Image courtesy of AbbVie

The patients in the U-EXCEED enrolled patients with Crohn’s disease who had a poor response or were intolerant to biologics. In the patient pool, more than 60% had failed two …

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AbbVie shares new Rinvoq data involving patients with psoriatic arthritis 

Abbvie’s 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 at the American College of Rheumatology (ACR) Convergence 2021 conference, AbbVie says the data underscore the drug’s potential for many people with psoriatic arthritis. “These data further add to the body of evidence that support the potential of upadacitinib to be an important treatment option that helps reduce the impact of the many disease manifestations of psoriatic arthritis,” said Dr. Thomas Hudson, senior vice president, research and development, chief scientific officer of AbbVie, in a press release.

Last year, Rinvoq generated $731 million in net revenues globally.

FDA approved Rinvoq in 2019 to treat m…

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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 to biologic disease-modifying antirheumatic drugs (bDMARD) therapy.

Rinvoq is a Janus kinase (JAK) inhibitor presently FDA indicated for moderately to severely active rheumatoid arthritis patients. The FDA indication specifically covers patients with a prior history of inadequate response or intolerance to the immunosuppressive drug methotrexate.

The study used the Assessment in SpondyloArthritis International Society (ASAS) 40 response by week 14 as a primary endpoint.

A total of 45% of Rinvoq recipients achieved an ASAS40 score at week 14 compared to 18% of placebo recipients. Similarly, 44% of…

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