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FDA rejects self-injectable version of AstraZeneca lupus drug
(Sharecast News) - The US health regulator has rejected an application by AstraZeneca to launch a self-injectable version of its lupus treatment Saphnelo, the drugs giant confirmed on Tuesday. The blue chip, which saw trading in its New York-listed shares go live on Monday, said it had received a complete response letter (CRL) from the US Food and Drug Administration. The FDA issues CRLs if a treatment cannot be approved in its current form.
AstraZeneca said the original biologics license application (BLA) submitted to the FDA was based on a planned interim analysis of a phase III trial evaluating the subcutaneous administration of Saphnelo, which met the primary endpoint.
However, it added that it was "committed to working with the FDA to progress the application as quickly as possible", noting that it had already given the regulator the additional information requested in the CRL.
The FDA's decision is now expected in the first half of 2026. The intravenous version of Saphnelo remains commercially available.
Systemic lupus erythematosus is a chronic and complex autoimmune disease affecting more than 3.4m people globally.
The European Union approved the subcutaneous formulation for adult patients with moderate-to-severe lupus in December.
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