Overview

• Novartis says the U.S. list price is $4,521 for 30 days, with availability to patients in the coming days.
• Approval rests on two late-stage trials showing significant gains over placebo in itch, hive counts, and overall disease activity.
• The company reports some patients reached well-controlled disease by week 2 and about one-third had no hives or itch by week 12.
• Novartis says the safety profile requires no lab monitoring and the drug targets BTK to temper overactive immune responses.
• Regulatory filings are complete in the European Union and Japan, and China has granted a priority review; further studies are underway in other immune conditions.