CHMP recommends Cosentyx for the treatment of adult patients with active non-radiographic axial spondyloarthritis. -Novartis

Novartis, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA). “Non-radiographic axial spondyloarthritis is part of the axSpA spectrum and is a painful and debilitating disease for which there are limited treatment options available,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology at Novartis. “This positive opinion marks another step forward in our commitment to reimagine medicine in axSpA and help patients realize relief from the burdensome symptoms of their disease earlier.” The positive CHMP opinion of Cosentyx for nr-axSpA is based on efficacy and safety outcomes from the PREVENT Phase III study, which included 555 adults with active nr-axSpA with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Cosentyx met the primary endpoint, achieving statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured by at least a 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) response criteria in biologic-naïve individuals at Week 16..