AstraZeneca announced that FDA rejected its application for a subcutaneous version of its lupus therapy Saphnelo, delaying a potential approval in the United States until the first half of 2026.

The FDA issued a complete response letter (CRL) for the easier-to-use formulation which is designed to be injected under the skin, allowing patients to self-administer the drug at home rather than receive intravenous infusions in a clinic or hospital setting.¹

According to AstraZeneca, the company has since submitted the additional information requested by the agency and will continue working with regulators, while the intravenous version of Saphnelo remains approved and marketed in more than 70 countries.

The U.S. setback stands in contrast to recent progress in Europe, where regulators have already approved the subcutaneous formulation for adult patients with moderate to severe systemic lupus erythematosus.¹

Ruud Dobber, executive vice president of the BioPharmaceuticals business unit at AstraZeneca, said: “We are committed to improving lupus care and since launch, Saphnelo IV infusion has transformed outcomes for tens of thousands of people living with systemic lupus erythematosus. With approximately 70% of SLE patients on biologics in Europe using a subcutaneous self-administration option, today’s approval means we can now offer the clinically meaningful benefits of Saphnelo while expanding patient choice in how and where they receive treatment.”

Lupus, a chronic autoimmune disease in which the immune system attacks healthy tissue and can lead to irreversible organ damage, affects more than 3.4 million people globally, underscoring the demand for therapies that are both effective and easier to use over the long term.

Investors reacted negatively to the regulatory news, with AstraZeneca shares falling more than 1.5% in early trading.¹ Saphnelo represents a small portion of the company’s overall revenue as the drug generated $483 million in the first nine months of 2025, about 1% of total sales during the period, making the product a meaningful contributor within AstraZeneca’s immunology portfolio.¹

Why did FDA reject the application?

The FDA decision came despite positive clinical data supporting the subcutaneous formulation. In the Phase III TULIP-SC trial, Saphnelo met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in disease activity compared with placebo in patients with systemic lupus erythematosus.²

Full results showed that 56.2% of patients receiving subcutaneous Saphnelo achieved a reduction in disease activity at Week 52, compared with 37.1% in the placebo group, as measured by the British Isles Lupus Assessment Group–based Composite Lupus Assessment.² The safety profile also remained consistent with that observed for the intravenous formulation.

For AstraZeneca, the subcutaneous version of Saphnelo is part of a broader strategy to expand the drug’s reach and improve patient convenience across multiple autoimmune indications. Ongoing trials are evaluating the therapy in conditions including cutaneous lupus erythematosus, myositis, systemic sclerosis, and lupus nephritis, reflecting continued interest in extending the franchise beyond its initial approval.

Sources

1. US FDA rejects AstraZeneca's easier-to-use version of lupus therapy Reuters February 3, 2026 https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-rejects-astrazenecas-application-lupus-drug-be-given-under-skin-2026-02-03/
2. Saphnelo self-administration TULIP-SC trial demonstrates statistically significant and clinically meaningful reduction in systemic lupus erythematosus disease activity AstraZeneca January 6, 2026 https://www.astrazeneca.com/media-centre/press-releases/2026/saphnelo-self-administration-tulip-sc-trial-demonstrates-statistically-significant-clinically-meaningful-reduction-sle-disease-activity.html
3. Saphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus AstraZeneca December 16, 2025 https://www.astrazeneca.com/media-centre/press-releases/2025/saphnelo-approved-in-the-eu-for-subcutaneous-self-administration-as-a-new-pre-filled-pen-for-systemic-lupus-erythematosus.html