Feb 3 (Reuters) – AstraZeneca said on Tuesday that the U.S. health regulator had rejected its application for an easier-to-use version of lupus therapy Saphnelo, pushing back the timeline for a possible approval to the first half of 2026.
The FDA setback contrasts with the European Union’s approval of the subcutaneous formulation of Saphnelo for adult patients with moderate to severe systemic lupus erythematosus (SLE), which affects more than 3.4 million people globally.
The Anglo-Swedish drugmaker’s shares fell by more than 1.5% in early trading after it said the U.S. Food and Drug Administration (FDA) had issued a complete response letter for the subcutaneous version of Saphnelo.
This delivers the therapy under the skin, allowing patients to inject the drug themselves at home rather than receiving intravenous infusions at a clinic or hospital.
AstraZeneca said it has since provided the information requested and will continue working with the FDA to advance the application, while the intravenous version of Saphnelo, approved in over 70 countries, remains on the market.
TRIAL SUCCESS FAILS TO SWAY FDA
The FDA rejection came despite the therapy meeting its primary goal in a late-stage trial by significantly reducing activity in SLE, a chronic autoimmune disease where the immune system attacks healthy tissue and may even lead to organ failure.
AstraZeneca is also working on expanding Saphnelo’s reach with ongoing trials in other chronic conditions such as cutaneous lupus erythematosus, myositis, systemic sclerosis and lupus nephritis.
Under a licensing deal updated in 2025, it will pay Bristol Myers Squibb a royalty on U.S. sales of Saphnelo.
The therapy generated $483 million for AstraZeneca in the first nine months of 2025, or about 1% of total revenue in the period.
(Reporting by Raechel Thankam Job in Bengaluru; Editing by Sherry Jacob-Phillips and Alexander Smith)
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