NVS Wins FDA Nod for Label Expansion of Immunology Drug Rhapsido

Novartis received FDA approval for Rhapsido (remibrutinib) for symptomatic dermographism (SD), making it the only prescription treatment approved for both CSU and SD, the two most common forms of chronic hives. The approval was supported by phase III RemIND trial data showing 29.3% complete hive resolution at week 12 versus 14% for placebo. The company is also evaluating remibrutinib in multiple sclerosis, hidradenitis suppurativa, and food allergy. However, Novartis faces pipeline setbacks with failed trials for pelacarsen and del-desiran, and generic competition pressuring blockbuster drugs.