“Since its launch, Saphnelo IV infusion has helped tens of thousands of people with systemic lupus erythematosus achieve lower disease activity with fewer steroids and has been shown to help many achieve remission. The approval of the Saphnelo Pen represents a significant step forward in expanding Saphnelo’s clinical benefits to more people living with systemic lupus erythematosus,” says Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca.

The Phase III TULIP-SC trial

The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE while receiving standard therapy. The safety profile observed was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.

Saphnelo

Subcutaneous administration of Saphnelo is approved in the EU and Japan and under regulatory review in several other countries around the world. Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide, including the US and EU. To date, more than 40,000 patients globally have been treated with Saphnelo. Saphnelo IV is the first biologic with remission data in SLE from a four-year placebo-controlled Phase III trial (TULIP-LTE) and was measured with the DORIS criteria for remission.

Financial considerations 

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 (BMS) in 2009. Under the agreement, updated in 2025, AstraZeneca will pay BMS a mid-teens royalty for sales in the US.