AstraZeneca wins FDA approval for Saphnelo Pen in SLE following Phase III success
FDA clears AstraZeneca’s Saphnelo Pen for patient self-injection of anifrolumab-fnia in SLE after Phase III TULIP-SC trial showed significant disease activity reduction versus placebo. Subcutaneous approval expands US SLE market opportunity, complementing IV use in over 70 countries and triggering mid-teens royalty payments to Bristol-Myers Squibb under the 2025 agreement.
1. FDA Approval of Saphnelo Pen
The FDA has approved the Saphnelo Pen autoinjector for adult patients with systemic lupus erythematosus to self-administer anifrolumab-fnia subcutaneously. This approval allows patients on standard therapy to inject at home rather than receiving an intravenous infusion.
2. TULIP-SC Trial Results
The Phase III TULIP-SC trial demonstrated that subcutaneous Saphnelo significantly reduced SLE disease activity compared to placebo in patients maintaining standard care. Safety findings aligned with the established profile of the intravenous formulation, supporting its broader use.
3. Market Expansion and Financial Terms
Subcutaneous approval in the US complements existing authorizations in Japan and the European Union, with submissions pending in additional markets. Under a revised 2025 agreement, AstraZeneca will pay mid-teens percentage royalties to Bristol-Myers Squibb on US sales of Saphnelo.