Novartis Receives FDA Approval For Xolair In CIU

Novartis announced it has received approval from the U.S. Food and Drug Administration (FDA) for Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU).

David Epstein, Division Head of Novartis Pharmaceuticals, said, “This approval from the FDA is great news for patients in the US suffering from CIU, a skin disease known as CSU in other parts of the world. Up to 50% of patients do not respond to approved doses of H1-antihistamines, which up until now have been the only licensed treatment for CIU in the US.”

CIU is known outside U.S. as chronic spontaneous urticaria (CSU), a severe and distressing skin disease. It is usually characterized by swollen, red, itchy, and occasionally painful hives on the skin which can erupt spontaneously and recur for over six weeks. Chronic urticaria affects up to 1% of the world’s population at any given time. Up to two thirds of these patients have CIU or CSU.

Xolair is a targeted therapy designed to bind to immunoglobulin E (IgE), which is thought to help in suppressing histamine-induced skin reactions. The drug is indicated for CIU in adults and adolescents 12 years old and above who still suffer from symptoms in spite of H1-anthistamine treatments. Until the approval of Xolair, H1-antihistamines have been the only approved treatment for CIU in the U.S.

The approval of Xolair is based on positive results from two landmark Phase III studies ASTERIA I and II, where the drug met its primary endpoints of reducing and clearing symptoms.

The drug has recently won approval from the European Commission as add-on therapy for CSU in adult and adolescent patients 12 years of age and older with insufficient response to standard H1-antihistamine therapies. Regulatory reviews for the approval of Xolair are ongoing in more than 20 countries.