FDA Rejects Self-Injected Version of Astra’s Lupus Drug (2)

Feb. 3, 2026, 9:36 AM UTC

The US Food and Drug Administration turned down a self-administered version of AstraZeneca Plc’s lupus medicine, but the UK drugmaker said it’s still working with regulators to advance the request.

Astra provided the information the FDA requested in a complete response letter and will work to “progress the application as quickly as possible,” it said Tuesday. The stock fell as much as 1.9% in early London trading, almost wiping out its gains for the year.

The medicine, Saphnelo, is already approved as an intravenous treatment, meaning it has to be injected in a vein and requires going to ...

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