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US FDA rejects AstraZeneca's ( AZNCF ) subcutaneous Saphnelo

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AstraZeneca ( AZNCF ) to keep working with FDA on application

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Shares in AstraZeneca ( AZNCF ) fall by more than 1.5%

(Adds shares in paragraph 3, background in paragraphs 6-9)

Feb 3 (Reuters) - AstraZeneca ( AZNCF ) 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 ( AZNCF ) 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 ( AZNCF ) 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 ( BMY ) ​a royalty on U.S. sales of Saphnelo.

The therapy generated $483 million for AstraZeneca ( AZNCF ) in the

first nine months of 2025, or about 1% of total revenue in the

period.