The FDA issued a complete response letter (CRL) rejecting AstraZeneca's application for the subcutaneous self-injectable version of Saphnelo (anifrolumab) for adult patients with moderate to severe systemic lupus erythematosus (SLE) on standard therapy.1
AstraZeneca plans to resubmit the application after addressing FDA concerns, with a decision expected in the first half of 2026.13
The intravenous formulation of Saphnelo remains approved and available in the US since 2021.1
The rejection focuses on manufacturing and formulation issues, not efficacy; Phase 3 TULIP-SC trial showed 56.2% response rate for subcutaneous Saphnelo.1
AstraZeneca's stock declined following the announcement, seen as a setback for patient convenience over IV administration.1
The subcutaneous version was approved in Europe.2
Sources:
1. https://mlq.ai/news/astrazeneca-receives-fda-rejection-for-saphnelo-subcutaneous-delivery-in-lupus-patients/
2. https://pharmaphorum.com/news/fda-knocks-back-astrazenecas-self-injected-lupus-drug
3. https://www.lupus.org/news/update-selfadministered-saphnelo-remains-under-fda-review-in-the-us