Xolair (Genentech+ Novartis) filed at FDA for Urticaria

Genentech/Roche has announced that the FDA has accepted and filed the company�s supplemental Biologics License Application (sBLA) for subcutaneous use of Xolair (omalizumab) in people with Chronic Idiopathic Urticaria (CIU) who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses. Xolair is jointly developed by Genentech and Novartis Pharma AG and is co-marketed in the United States with Novartis Pharmaceuticals Corporation. The FDA action date is second quarter of 2014.

The sBLA was primarily based on two, global, multi-center, randomized, double-blind, placebo-controlled Phase III studies (ASTERIA I and ASTERIA II) in a total of 642 (319 and 323, respectively) patients with moderate-to-severe CIU who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses. A third study (GLACIAL) was a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 336 patients to primarily evaluate the safety profile of Xolair as an add-on therapy in CIU patients who remained symptomatic despite other treatments with antihistamine.