Shots:
- The EC has approved AstraZeneca’s Saphnelo (anifrolumab; 120mg, SC, QW, PFS) for the treatment of adults with SLE in combination with SoC; regulatory review is ongoing in the US & Japan
- Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC, which showed Saphnelo reduced disease activity (1EP)
- 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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