Business
Update on Saphnelo subcutaneous administration
AstraZeneca has received a complete response letter from the US FDA regarding the Biologics License Application for Saphnelo's subcutaneous administration in systemic lupus erythematosus, and a decision on the updated application is expected in the first half of 2026, while intravenous Saphnelo remains available. The original application was based on the TULIP-SC trial, which met its primary endpoint, and the safety profile was consistent with the intravenous formulation. In December 2025, Saphnelo subcutaneous administration was approved in the EU, and the full analysis of the TULIP-SC trial, published in January 2026, also demonstrated efficacy. Over 40,000 patients globally have been treated with Saphnelo IV, which is approved in over 70 countries. AstraZeneca will pay Bristol-Myers Squibb a mid-teens royalty for US sales under an updated agreement. Disclaimer*
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n3 February 2026\nUpdate on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus\nThe US Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo (anifrolumab) for subcutaneous administration in adult patients with systemic lupus erythematosus (SLE). AstraZeneca subsequently provided the information requested in the CRL and is committed to working with the FDA to progress the application as quickly as possible.\n \nA decision from the FDA on the updated application for Saphnelo SC is expected in the first half of 2026. Intravenous (IV) Saphnelo remains commercially available.\n \nThe original BLA submitted to the FDA by AstraZeneca was based on a planned interim analysis of the Phase III TULIP-SC trial evaluating the subcutaneous administration of Saphnelo, which met the primary endpoint. The safety profile observed in the TULIP-SC trial was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.1-4\n \nIn December 2025, AstraZeneca announced the approval of Saphnelo in the European Union (EU) for subcutaneous administration in adult patients with moderate to severe SLE. Since then, the full analysis of the TULIP-SC trial also demonstrated the subcutaneous administration of Saphnelo met the primary endpoint of reduction in disease activity. These results were published in Arthritis & Rheumatology in January 2026. \n \nSaphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide including the US, EU and Japan. To date, more than 40,000 patients globally have been treated with Saphnelo.5\nNotes\n \nFinancial considerations \nAstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. 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. \n \nSystemic lupus erythematosus\nSLE is an autoimmune disease in which the immune system attacks healthy tissue in the body.6 ...