AstraZeneca: FDA Approves Saphnelo For Subcutaneous Self-administration

(RTTNews) - AstraZeneca (AZN, AZN.L, ZEG.DE, AZN.ST) said its Saphnelo has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus on top of standard therapy. The approval was based on results from the Phase III TULIP-SC trial. Subcutaneous administration of Saphnelo is approved in the EU and Japan and under regulatory review in several other countries.

AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, in 2004. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb in 2009. Under the agreement, updated in 2025, AstraZeneca will pay Bristol-Myers Squibb a mid-teens royalty for sales in the US.

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