AAD25: Ahead of CSU filing, Novartis’ BTK inhibitor shows sleep benefits
New Sleep Improvement Data
- New data presented at AAD 2025 shows remibrutinib improved sleep and daily activities in CSU patients
- Results come from the Phase 3 REMIX-1 and REMIX-2 trials of remibrutinib in CSU
- Remibrutinib led to early achievement of no impact on sleep (SIS7=0) and daily activities (AIS7=0) in more patients vs placebo
- Improvements were seen as early as Week 2 and continued through Week 24
Significance of Sleep Benefits
- Sleep disturbances are a major issue for CSU patients, occurring almost twice as frequently as in people without CSU
- Improving sleep and daily functioning is an important goal of CSU treatment
- These sleep/activity results complement previously reported efficacy data on itch and hive reduction
Regulatory Filing Plans
- Novartis plans to submit remibrutinib for approval in CSU to global health authorities in the first half of 2025
- The sleep/activity data adds to the overall clinical evidence package supporting approval
About Remibrutinib
- Oral Bruton's tyrosine kinase (BTK) inhibitor
- Blocks BTK cascade and prevents histamine release that causes CSU symptoms
- Could potentially disrupt CSU treatment landscape currently dominated by injectable biologics
In summary, these new sleep improvement results further strengthen remibrutinib's clinical profile in CSU as Novartis prepares for regulatory submissions later this year. The data demonstrates benefits beyond just symptom control, addressing key quality of life issues for patients.