Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (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 and is co-marketed in the US with Novartis Pharmaceuticals.
The FDA action date is second quarter of 2014.
CIU, also known as chronic spontaneous urticaria (CSU), is a skin condition characterized by red, swollen, itchy hives.
Genentech chief medical officer and global product development head Hal Barron noted the company is pleased that the FDA has filed its application for Xolair for chronic idiopathic urticaria.
"We hope we can soon bring our medicine to people with this chronic form of hives," Barron added.
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 antihistamines.
