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Find Clinical Drug Development Pipelines & Deals | PipelineProspector
SELECT-AXIS 2 highlights efficacy and safety data of upadacitinib (RINVOQ®) in patients with non-radiographic axial spondyloarthritis, and in patients with radiographic axial spondyloarthritis with an inadequate response to biologic disease-modifying antirheumatic drugs.
Submissions supported by Phase 3 study in which upadacitinib (RINVOQ®) demonstrated significant improvements in signs and symptoms as well as physical function and disease activity versus placebo.
CHMP positive opinion is based on data from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2 studies of SKYRIZI® (risankizumab), an interleukin-23 (IL-23) inhibitor for treatment of chronic immune-mediated diseases.
In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved the primary endpoint of ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo.
Across pivotal clinical trial programs, RINVOQ (15 mg, once daily) demonstrated efficacy across multiple measures of disease activity in psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a safety profile consistent with that seen in rheumatoid arthritis.
The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.
Submissions supported by two Phase 3 studies in which RINVOQ demonstrated improved joint outcomes, physical function and skin symptoms, with a greater proportion of patients achieving minimal disease activity versus placebo.
In this large Phase 3 study, RINVOQ™ (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis.
AYVAKIT (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced SM, including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL).
SM04690 (lorecivivint), demonstrated clinical efficacy in earlier, less structurally damaged patients, although these trials fell short of reaching statistical significance in their primary endpoints of Pain NRS (daily pain score) at week 12 with all subjects.
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