Feb 3 (Reuters) – AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable version of lupus drug Saphnelo, pushing back the approval timeline for a possible approval to the first half of 2026.
The U.S. Food and Drug Administration (FDA) issued a complete response letter for the subcutaneous version of Saphnelo, which would allow patients to inject the drug themselves at home rather than receiving intravenous infusions at a clinic or hospital.
The Anglo-Swedish drugmaker said it has since provided the information requested by the FDA and will continue working with the regulator to advance the application, while the intravenous version of Saphnelo remains commercially available.
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The rejection occurred even as the drug met its primary goal in a late-stage trial by significantly reducing activity in systemic lupus erythematosus (SLE), a chronic autoimmune disease that affects more than 3.4 million people globally.
Last December, the European Union had approved the subcutaneous formulation for adult patients with moderate to severe SLE.
(Reporting by Raechel Thankam Job in Bengaluru; Editing by Sherry Jacob-Phillips)
