Novartis Cosentyx includes axial manifestation management data for psoriatic arthritis in EU label

Compilenewborn

Novartis recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved the final opinion on the changes to the class II label of the anti-inflammatory drug Cosentyx (generic name: secukinumab, secukinumab).

PsA patients with axial manifestations have a higher disease burden, pain, fatigue, morning stiffness, impaired physical function, increased attachment point count, and higher levels of inflammation markers.

Cosentyx is the only fully human interleukin 17A (IL-17A) inhibitor that has proven efficacy and safety in a phase IIIb study that specifically evaluates the axial performance of PsA.

Currently, Cosentyx has been approved for indications: plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and radiology-negative axial spondyloarthritis (nr-axSpA).

The EU label update has strengthened Cosentyx's leadership in rheumatism and immune skin diseases.

MAXIMISE is a 52-week double-blind, randomized, placebo-controlled Phase IIIb study that evaluated the efficacy and safety of Cosentyx in the management of PsA axial manifestations.

In the study, patients received a subcutaneous injection of Cosentyx 300mg or 150mg once a week for 4 weeks, and then every 4 weeks.

The results showed that the study reached the primary and key secondary endpoints: in the 12th week of treatment, 62.