AstraZeneca Faces FDA Rejection for Easier Lupus Treatment

On Tuesday, AstraZeneca experienced a blow when the U.S. Food and Drug Administration (FDA) turned down its submission to have a simpler subcutaneous form of Saphnelo, which is a lupus treatment. The delay of the potential approval of this subcutaneous formulation by the FDA is what moves it to the first half of 2026.

This is in contrast to the European Union approving the subcutaneous form of Saphnelo on adult patients with moderate to severe systemic lupus erythematosus (SLE), a chronic autoimmune disease affecting more than 3.4 million users worldwide.

After the decision of the FDA, the share price of AstraZeneca decreased by over 1.5 percent during the early trading. The rejection was due to the full response letter of the FDA, although the therapy achieved its major objective in a late clinical study, where it greatly lessened SLE activity.

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The subcutaneous would have enabled the patients to administer the drug from the comfort of their homes through self-injection, which would be intravenous injections as opposed to the clinic-based intravenous infusions. As AstraZeneca liaises with the FDA to respond to the requested information and work forward with the application, the intravenous form of Saphnelo is currently being used in more than 70 countries.

AstraZeneca is still exploring the potential of Saphnelo in other chronic diseases like cutaneous lupus erythematosus, myositis, systemic sclerosis, and lupus nephritis. The treatment brought AstraZeneca a revenue of 483 million during the first 9 months of 2025, which is approximately 1 percent of the total revenue.