Also known as: CYP3A4
The FDA approved Lupin's generic pitolisant tablets as bioequivalent to WAKIX, and approved Harmony Biosciences' WAKIX for pediatric cataplexy, making it the first non-controlled treatment for both pediatric and adult narcolepsy patients.
Nereus (tradipitant) is now commercially available for prevention of motion-induced vomiting. Vanda has launched a phase 3 trial in GLP-1 users, building on phase 2 results showing a 50% relative reduction in vomiting.
The U.S. Court of Appeals for the Federal Circuit ruled that Teva Pharmaceuticals did not infringe Corcept Therapeutics' patents for methods of safely co-administering Korlym with CYP3A4 inhibitors, affirming a 2023 district court verdict.
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.
