News
Cosentyx gains EU label update for first-of-its-kind MAXIMISE data in axial manifestations of psoriatic arthritis.- Novartis
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted the final opinion for a type II label variation for Cosentyx (secukinumab) to include data for axial manifestations of psoriatic arthritis (PsA), from the first-of-its-kind MAXIMISE trial
PsA patients with axial manifestations report higher disease burden with higher levels of pain, fatigue, morning stiffness, impairment of physical function, increased enthesitis count and higher levels of inflammatory markers. They also report worse quality of life and/or work productivity.
Cosentyx is the only fully human interleukin (IL)-17A inhibitor to demonstrate efficacy and safety in a dedicated Phase IIIb study of axial manifestations in PsA. It is the first biologic with proven efficacy in all six key manifestations of PsA including peripheral disease, enthesitis, dactylitis, skin psoriasis and nail psoriasis.
Condition: Psoriatic Arthritis
Type: drug