Shots:
- The US FDA has approved AstraZeneca’s Saphnelo pen (anifrolumab; 120mg, SC, QW, autoinjector) for the treatment of adults with SLE in combination with SoC
- Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo pen vs PBO in 367 pts (18-70yrs.) with mod. to sev. SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP); full results were published in Arthritis & Rheumatology
- AstraZeneca gained global rights to Saphnelo through an exclusive license agreement in 2004 with Medarex, whose co-promotion option lapsed upon its 2009 acquisition by BMS, & will pay BMS low to mid-teens sales royalties based on geography
Ref: AstraZeneca | Image: AstraZeneca |Press Release
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