FDA accepts, files Genentech's sBLA for subcutaneous use of Xolair in people with CIU

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. 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 AG and is co-marketed in the United States with Novartis Pharmaceuticals Corporation. 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. It is diagnosed when hives spontaneously present without an identifiable cause and reoccur for more than six weeks. Some 30-50 percent of CIU patients also have angioedema, where swelling occurs under the skin instead of on the surface. The prevalence of CIU is approximately 0.5 to 1 percent of the worldwide population. Currently, H₁-antihistamines are the only approved therapy for patients suffering from CIU.

"We are pleased that the FDA has filed our application for Xolair for chronic idiopathic urticaria," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We hope we can soon bring our medicine to people with this chronic form of hives."

Development Program

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.

SOURCE Genentech