Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 2 days ago
- 2 min read
Updated: 1 day ago
22/04/2026
Roche announced Phase 3 data for fenebrutinib in RMS (Ref)
Roche announced new positive data from the Phase 3 FENhance 1 and 2 studies, Which investigated fenebrutinib (BTK inhibitor) for the treatment of patients with Relapsing Multiple Sclerosis (RMS).
FENhance 1 and 2 studies met their primary endpoint and reduced the annualised relapse rate (ARR) by 51.1% (p<0.001) in FENhance 1 and 58.5% (p<0.0001) in FENhance 2 compared with teriflunomide in patients with RMS over 96 weeks.
This equates to patients having approximately one relapse every 17 years, more than half the relapses seen with teriflunomide in the same period of time.
The results were shared as a late-breaking presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting.
The totality of RMS and PPMS data for fenebrutinib was submitted to regulatory authorities.
Johnson & Johnson announced Phase 3 data for nipocalimab in gMG (Ref)
Johnson & Johnson announced new data from the Phase 3 Vivacity-MG3/ NCT04951622 study and ongoing open label extension (OLE) in a broad population of antibody-positive (including anti-AChR+a and anti-MuSK+b) adults with generalized myasthenia gravis (gMG).
IMAAVY delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+ through 120 weeks of follow-up.
Patients who achieved sustained minimal symptom expression (MSE) experienced greater improvements in quality of life than those who had transient MSE in a post-hoc analysis of the Phase 3 study.
Sanofi's Tzield approved in the US to delay the onset of stage 3 T1D in young children (Ref)
Sanofi announced that the US FDA had approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D.
The approval was granted under a priority review process and is supported by one-year data from the Phase 4, PETITE-T1D/ NCT05757713 study.
Tzield was also being reviewed by the FDA for a potential indication to delay the progression of stage 3 T1D in patients eight years of age and older recently diagnosed with stage 3 T1D.
