Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Apr 29
- 2 min read
27/04/2026
AbbiVe submitted a regulatory application to the FDA for risankizumab for adults with moderately to severely active CD (Ref)
AbbiVe announced that it had submitted an application to the US FDA seeking approval for SKYRIZI® (risankizumab; IL-23 inhibitor) for subcutaneous induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD).
The application was supported by positive data from the Phase 3, AFFIRM/ NCT06063967 study.
AbbVie anticipated FDA approval for this new dosing regimen for SKYRIZI later this year.
Saphnelo was approved in the US for subcutaneous self-administration for the treatment of SLE (Ref)
AstraZeneca announced that Saphnelo (anifrolumab; type 1 IFNR) had been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.
The approval by the US FDA was based on results from the Phase 3, TULIP-SC/ NCT04877691 study, which showed that SC administration of Saphnelo had led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with moderate to severe SLE who were receiving standard therapy.
The safety profile observed was consistent with the known clinical profile of Saphnelo administered as an intravenous infusion.
Novartis announced that remibrutinib had received EU approval for the treatment of chronic spontaneous urticaria (Ref)
Novartis announced that the European Commission had approved Rhapsido® (remibrutinib; BTK inhibitor) for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment.
Rhapsido had received a positive opinion in February 2026 from the CHMP of the European Medicines Agency.
Rhapsido was recommended in 2026 International Urticaria Guideline for all patients who remain symptomatic after H1-antihistamine treatment.
The FDA granted Priority Review for nipocalimab for the treatment of wAIHA (Ref)
Johnson & Johnson announced that the US FDA had granted Priority Review to the supplemental Biologics License Application for IMAAVY® (nipocalimab; FcRn blocker) for the treatment of warm autoimmune hemolytic anemia (wAIHA).
The Priority Review was supported by results from the Phase 2/3, ENERGY/ NCT04119050 study.
The ENERGY study showed that more patients treated with IMAAVY had achieved a durable hemoglobin response compared with placebo, along with improvements in fatigue, critical outcome for people living with wAIHA.
