AstraZeneca (AZN) said Tuesday it expects a decision in H1 this year from the US Food and Drug Administration on its updated application for subcutaneously administered Saphnelo as a treatment for adults with systemic lupus erythematosus, a chronic autoimmune disease.
The FDA issued a complete response letter regarding the biologics license application for subcutaneous Saphnelo, which is already approved in intravenous form.
AstraZeneca said it subsequently provided additional information.
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