Basel, 11 October 2013
FDA files Genentech's supplemental biologics license application of Xolair (omalizumab) for chronic idiopathic urticaria (CIU)
- CIU is a skin condition characterized by red, swollen, itchy hives on the skin
- Currently, H1-antihistamines are the only approved therapy for patients suffering from CIU,also known as chronic spontaneous urticaria (CSU)
- FDA decision on sBLA expected during second quarter of 2014
Roche (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), a form of chronic hives 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 on the skin.1,3 It is diagnosed when hives spontaneously present without an identifiable cause and reoccur for more than six weeks1. 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.2 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.”
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.
XOLAIR (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients 12 years of age and older for patients with moderate to severe persistent allergic asthma caused by year-round allergens in the air. A skin or blood test is done to see if you have allergic asthma. XOLAIR is for patients who are not controlled by asthma medicines called inhaled steroids.
XOLAIR helps reduce the number of asthma attacks in people with allergic asthma who still have asthma symptoms even though they are taking inhaled steroids.
XOLAIR has not been proven to work in other allergic conditions.
XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks.
XOLAIR should not be used in children under 12 years of age.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
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1) Asthma and Allergy Foundation of America (AAFA) website. “Chronic Urticaria (Hives).” http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed August 6, 2013.
2) Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66: 317–330.
3) American Academy of Allergy Asthma & Immunology (AAAAI) website. “Skin Allergy Overview.” http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed August 6, 2013.