AstraZeneca PLC (LSE:AZN) shares slipped around 1.5% in early trading after the US regulator declined to approve the company’s initial application for a subcutaneous injection version of its lupus treatment Saphnelo.
The group said it received a complete response letter from the U.S. Food and Drug Administration, indicating that the filing could not be approved in its current form. AstraZeneca has since submitted the additional information requested and said it is working closely with the regulator to progress the application as quickly as possible. A regulatory decision on the resubmission is now expected in the first half of 2026.
Saphnelo, which is used to treat the autoimmune condition systemic lupus erythematosus (SLE), continues to be marketed in the US in its already-approved intravenous infusion format. The original application for the injection version was supported by an interim analysis from the Phase III TULIP-SC study, which showed that subcutaneous dosing met the trial’s primary endpoint and had a safety profile consistent with the intravenous formulation.
AstraZeneca noted that the regulatory setback in the US contrasts with progress elsewhere. The subcutaneous form of Saphnelo was approved in the European Union in December 2025 for adults with moderate to severe SLE. Full results from the TULIP-SC trial, published in January 2026, confirmed that the injection met its primary endpoint of reducing disease activity.
The company added that Saphnelo is now approved for the treatment of moderate to severe SLE in more than 70 countries globally, including the US, EU and Japan, and has been used to treat over 40,000 patients worldwide.
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