- Cosentyx® (secukinumab) is the first biologic with proven efficacy in all 6 key manifestations of psoriatic arthritis (PsA), and the only biologic with fast and lasting relief of axial manifestations of PsA in a dedicated trial1,2,3.
- Up to two-thirds of patients with PsA suffer from axial manifestations4
- Phase IIIb MAXIMISE trial showed treatment with Cosentyx improved the signs and symptoms of axial manifestations of PsA as early as Week 4; response was maintained up to Week 52, with a consistently favorable safety profile1
- Cosentyx is an established brand, supported by long-term 5-year sustained efficacy and safety data across psoriasis, PsA and ankylosing spondyloarthritis (AS)2,3,5–7, with 400,000+ patients treated worldwide since launch8
Basel, February 26, 2021 — Novartis announced today 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 trial1.
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 markers9,10. They also report worse quality of life and/or work productivity11.
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 PsA1. It is the first biologic with proven efficacy in all six key manifestations of PsA including peripheral disease, enthesitis, dactylitis, skin psoriasis and nail psoriasis2,3.
The label update reinforces Cosentyx leadership in rheumatology and immuno-dermatology, with plans to expand to 10 indications over the next 10 years.