AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo

Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...

AI Summary: AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market.

---

Warning: Undefined variable $thumbnail in /home3/thegood9/public_html/website_70aad9ea/cluster.php on line 61

Related Stories

---

Warning: Undefined variable $top_stories in /home3/thegood9/public_html/website_70aad9ea/cluster.php on line 128

FDA lifts holds on Intellia’s Phase 3 gene-editing trials / 2 months

FDA rejects Disc Medicine’s rare-disease drug despite priority review / 3 months

Axpaxli outperforms Eylea in Phase 3; FDA filing expected / 3 months

BridgeBio’s dwarfism drug posts positive Phase 3 data, FDA filing on track / 3 months

FDA Accepts Summit Therapeutics' Ivonescimab BLA for EGFR‑Mutant NSCLC / 4 months

FDA Lifts Hold on Intellia’s Phase 3 Gene Editing Trial / 4 months

FDA rejects Corcept’s cortisol modulator triggering setback / 4 months