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

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