Genentech Ph III study of omalizumab shows promise in CIU

Genentech, the US biotech subsidiary of Swiss drug major Roche (ROG: SIX), announced results from a Phase III trial, ASTERIA II, which demonstrated that omalizumab met its primary endpoint in patients with moderate to severe chronic idiopathic urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses.

The data on omalizumab, the active ingredient of fellow Switzerland-based Novartis’ (NOVN: VX) asthma drug Xolair which is co-promoted by Genentech and Roche, were published yesterday in the New England Journal of Medicine and will be presented tomorrow at the American Academy of Allergy, Asthma and Immunology annual meeting in San Antonio, Texas.

CIU, also referred to as chronic spontaneous urticaria (CSU) outside the USA, is a skin condition characterized by red, swollen, itchy hives on the skin and is diagnosed when hives spontaneously present and reoccur for more than six weeks. Angioedema, or swelling of the deep layers of skin, is common in patients with CIU. At any given time, the prevalence of CIU is around 0.5% to 1% worldwide. Currently, H1 antihistamines are the only approved therapy for patients suffering from CIU.