Subcutaneous anifrolumab is superior to placebo in multiple systemic lupus erythematosus disease activity measures at 52 ...
AstraZeneca has already provided the requested information to the FDA and a decision on the updated BLA is expected in the first half of 2026.
The FDA delays approval AstraZeneca lupus drug Saphnelo for subcutaneous use, pending additional data; intravenous form remains available globally.
The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in the first half of 2026.
The US Food and Drug Administration rejected a subcutaneous version of AstraZeneca Plc’s lupus medicine that would make it easier to administer.
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