Xolair is the first biologic medicine to be approved for CIU, a skin condition that can cause severe itching and can last for many years. Around 1.5M people in the U.S. develop CIU at some point in their lives.
"Nearly 50% of patients have inadequate response to H1-antihistamines, previously the only approved therapy for CIU," Roche says.
The FDA's authorization covers people 12 years old and older who still suffer symptoms of CIU despite treatment with H1-antihistamines.
Xolair is also approved for moderate-to-severe persistent allergic asthma. (PR)