AstraZeneca’s lupus therapy, Saphnelo (anifrolumab), received European Commission approval on December 16, 2025 for a new subcutaneous self‑administration format delivered via a pre‑filled pen. The approval extends the drug’s commercial reach in the EU and introduces a patient‑friendly delivery option that could improve adherence and broaden the product’s market potential.
Saphnelo had previously been approved for intravenous infusion, but the new subcutaneous formulation is based on the Phase III TULIP‑SC trial, which demonstrated a statistically significant and clinically meaningful reduction in disease activity among adults with systemic lupus erythematosus (SLE). The trial’s results confirmed that the pen‑based delivery is as safe and effective as the IV regimen, providing a compelling alternative for patients who prefer to manage treatment at home.
The approval is significant for both patients and payers. Approximately 70 % of SLE patients on biologic therapies in Europe already use subcutaneous self‑administration, so the new pen format aligns with prevailing patient preferences and could enhance adherence. By reducing the need for clinic visits, the format also offers potential health‑system cost savings, a factor that regulators and payers closely monitor when approving new delivery methods.
From a commercial perspective, the subcutaneous pen positions AstraZeneca to capture a larger share of the EU lupus market, a key component of its rare‑disease portfolio. The company’s rare‑disease strategy has been a focus of its diversification beyond oncology, and the expanded delivery format strengthens its competitive edge against other lupus therapies such as GSK’s Benlysta, which also offers a subcutaneous option.
Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, said, “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.” Professor Thomas Dörner, an investigator of the TULIP‑SC trial, added, “EU approval of anifrolumab in a self‑administered pre‑filled pen is fantastic news for people living with systemic lupus erythematosus as clinicians now have the potential to reach a wider group of patients with this important medicine.”
The European Commission’s decision follows ongoing regulatory reviews in other markets. AstraZeneca is actively pursuing approval for the subcutaneous formulation in the United States and Japan, where the drug’s market potential is also significant. The company’s strategy to secure approvals across multiple jurisdictions underscores its commitment to expanding access to Saphnelo worldwide.
In summary, the EU approval of Saphnelo’s subcutaneous pen marks a pivotal step in AstraZeneca’s rare‑disease strategy, offering patients a more convenient treatment option, potentially lowering health‑system costs, and positioning the company to capture a larger share of the EU lupus market while reinforcing its diversification beyond oncology.
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