What's Happening?
The FDA has issued a complete response letter to AstraZeneca, rejecting the self-injected version of its lupus drug Saphnelo. This decision comes despite the drug's recent approval in Europe. The self-injected formulation was intended to replace the intravenous version approved in 2021. AstraZeneca has provided additional information to the FDA and hopes for a decision in the first half of 2026. The intravenous version remains available, with sales rising 48% to $483 million in the first nine months of 2025.
Why It's Important?
The FDA's rejection of the self-injected Saphnelo formulation is a setback for AstraZeneca, potentially delaying its market expansion and affecting its competitive position. The self-injected version was expected to drive significant sales
growth, with projections of $1 billion to $3 billion in peak annual sales. This decision highlights the challenges pharmaceutical companies face in gaining regulatory approval, impacting their ability to innovate and expand treatment options for patients with systemic lupus erythematosus.
What's Next?
AstraZeneca plans to continue discussions with the FDA, aiming for approval of the self-injected Saphnelo formulation. The company is also focusing on other drug developments, including Datroway, which has received FDA priority review for treating metastatic triple-negative breast cancer. AstraZeneca's efforts to expand its product offerings and address unmet medical needs will be crucial in maintaining its market position.
