Novartis' Cosentyx (secukinumab) Receives EC's Approval for Axial Spondyloarthritis Spectrum Marking its Fourth Indication in EU
Shots:
- The approval is based on P-III PREVENT study involve assessing Cosentyx (150mg- SC with loading dose and 150mg with no loading dose) vs PBO in 555 adult patients with active nr-axSpA (with onset before 45yrs. of age- spinal pain rated as >=40/100 on a VAS and BASDAI >=4)- who had treated with at least two different NSAIDs at the highest dose up to 4wks. prior to study start
- The P-III PREVENT study resulted in meeting its 1EPs i.e. reduction in disease activity (41.5% vs 29.2%)- as measured by at least a 40% improvement in ASAS40 @16wks. with improvements continued through 52wks. and demonstrated improvements in 2EPs including pain- disease burden and health-related QoL
- Cosentyx is the first and only fully human biologic targeting IL-17A and is an approved therapy for PsO- PsA and AS. The company is working with the US FDA and PMDA for reviewing Cosentyx to treat adults with nr-axSpA
Click here to read full press release/ article
Ref: Novartis | Image: Novartis
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com
