AstraZeneca said the U.S. Food and Drug Administration has issued a complete response letter for the company’s application seeking approval of a subcutaneous version of its lupus treatment Saphnelo, delaying clearance for a formulation designed for self-administration.
The decision means AstraZeneca cannot yet market the monoclonal antibody in the United States through a prefilled pen that would allow patients to inject the therapy themselves. The company disclosed the FDA action in a press release dated Feb. 3, noting that the regulator had requested additional information as part of its review.
AstraZeneca said it has since provided the requested material and stated that it is “committed to working with the FDA to progress the application as quickly as possible,” according to the company. Despite the complete response letter, the drugmaker said it still expects a decision on the updated application during the first half of the year. In a separate statement, AstraZeneca said the FDA rejection pushes back the timeline for a possible U.S. approval to the first half of 2026.
The FDA setback comes after regulatory progress in Europe. In December, the European Medicines Agency approved the subcutaneous formulation of Saphnelo for adult patients with moderate to severe systemic lupus erythematosus. The formulation delivers the drug under the skin, allowing patients to administer treatment at home rather than receiving intravenous infusions at a clinic or hospital.
AstraZeneca has pointed to recent clinical data supporting the subcutaneous version. The company said a trial showed the therapy produced a statistically significant and clinically meaningful reduction in disease activity compared with placebo.
According to AstraZeneca, the efficacy and safety profile of the subcutaneous formulation was consistent with the intravenous version of Saphnelo, and patients treated with the drug were able to reduce their use of oral corticosteroids. The FDA response was issued despite the therapy meeting its primary endpoint in a late-stage study.
Saphnelo was originally approved by the FDA in 2021 for the treatment of systemic lupus erythematosus, becoming the first new therapy for the disease in a decade. GlaxoSmithKline’s Benlysta, another lupus treatment, received FDA approval for its own subcutaneous version in 2017. In the first nine months of 2025, Saphnelo generated $483 million in revenue for AstraZeneca, while Benlysta recorded sales of 2.7 billion pounds sterling over the same period. Benlysta’s sales have been supported by label expansions beginning in 2020 to include lupus nephritis.
Systemic lupus erythematosus affects more than 3.4 million people worldwide and primarily affects women, causing symptoms such as pain, fatigue, rashes, joint swelling, and fever. AstraZeneca has said that people with SLE in Europe face a two- to threefold higher risk of death compared with the general population. Oral corticosteroids are commonly used to manage symptoms but do not address the underlying drivers of the disease.
AstraZeneca gained worldwide rights to Saphnelo through a 2004 licensing and collaboration agreement with Medarex, which was later acquired by Bristol Myers Squibb. Under an updated version of the agreement, AstraZeneca pays Bristol Myers Squibb a mid-teens royalty on U.S. sales of the drug.
FDA Issues Complete Response Letter for Subcutaneous Saphnelo Application
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the subcutaneous Saphnelo Biologics License Application (BLA), meaning the agency has not approved the application in its current form and has requested additional information or revisions from the sponsor. AstraZeneca, the developer of Saphnelo, has since provided the requested materials and is working with the FDA to advance the review process. A final decision on the updated Saphnelo application is expected in the first half of 2026.
Regulatory Setback for Saphnelo Subcutaneous Version
The Saphnelo subcutaneous formulation — designed to allow patients to self-inject the treatment rather than receive intravenous infusions in a clinic — faced a setback when the FDA rejected the application and issued the CRL. This contrasts with the European Union’s approval of the Saphnelo self-injection option, which was granted previously.
Regulatory authorities indicated that the application was not approved in its current form due to outstanding review items rather than concerns about patient safety. Such letters are commonly issued when regulators require clarifications, additional analyses, or updates related to manufacturing processes or documentation.
Company representatives stated that they have already submitted the requested information and remain confident in the therapy’s clinical value. They emphasized that discussions with regulators have been constructive and focused on resolving technical issues efficiently.
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