Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
The FDA approved pitolisant (Wakix) for treating cataplexy in children ages 6 and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint for three prevalent CIndU types with significantly higher complete response rates versus placebo at Week 12.
The FDA has approved pitolisant tablets for treating cataplexy in pediatric patients aged 6 and older with narcolepsy, making it the only non-scheduled therapy approved for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA approved Harmony Biosciences' supplemental new drug application for WAKIX (pitolisant) to treat cataplexy in pediatric patients 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
