The Committee for Medicinal Products for Human Use (CHMP) recommends approving upadacitinib 15 mg, once daily, for the treatment of active non-radiographic axial spondyloarthritis in adults patients with inflammation and inadequate response to NSAIDs.
In a press release, AbbVie announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends approving upadacitinib 15 mg, once daily, for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients aged 18 years or older with inflammation and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Objective inflammation was determined via magnetic resonance imaging (MRI) and/or elevated C-reactive protein (CRP).
The approval was supported by results from the Phase 3, randomized, double-blind, placebo-controlled SELECT-AXIS 2 nr-axSpA study, which analyzed the efficacy and safety of the drug compared with placebo in 314 patients with a clinical diagnosis of nr-axSpA. Eligible patients had active inflammation and/or high sensitivity C-reactive protein (hs-CRP) > upper limit of normal (2.87 mg/L) at screening, with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and total back pain score of ≥4.
The study met the primary endpoint of Assessment of Spondyloarthritis International Society 40 (ASAS40) response criteria at week 14 when compared with placebo, as well as 12 of 14 secondary endpoints. No new safety risks were identified. The most common adverse reactions were upper respiratory tract infections, nausea, cough, increased aspartate transaminase (AST), increased blood creatine phosphokinase (CPK), increased alanine transaminase (ALT), bronchitis, and hypercholesterolemia.
Upadacitinib is currently approved in the EU for adults with moderate-to-severe active rheumatoid arthritis (RA) who have inadequate response or intolerability to at least 1 disease-modifying antirheumatic drug (DMARD), patients with psoriatic arthritis (PsA) who have inadequate response or intolerability to at least 1 DMARD, and patients with active ankylosing spondylitis (AS) who have inadequate response to conventional therapy.
"Patients with axSpA often experience delayed diagnosis and once they do receive a diagnosis, there are limited therapies available to help control disease symptoms, such as inflammation, back pain and stiffness,” Neil Gallagher, MD, PhD, Vice President, development, chief medical officer, AbbVie, stated. "The CHMP's recommendation to approve upadacitinib for patients with nr-axSpA is an important milestone in providing a new treatment option to patients in need."
The European Commission (EC) will review the CHMP positive opinion, with a decision anticipated in Q3 2022.