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FDA considers Xolair for chronic idiopathic urticaria
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The FDA has accepted and filed a supplemental biologics license application for the subcutaneous use of omalizumab in patients with chronic idiopathic urticaria with ongoing symptoms despite antihistamine therapy, Genentech has announced.
The FDA’s action on omalizumab (Xolair) was based on two double blind, placebo-controlled phase 3 studies in 642 patients with moderate to severe chronic idiopathic urticaria (CIU) who remained symptomatic despite treatment with H1-antihistamines, according to a press release. The drug’s safety profile as add-on therapy for CIU patients who remained symptomatic despite previous antihistamines was conducted in a third parallel-group trial on 336 patients.
Genentech and Novartis Pharma AG co-market Xolair in the United States with Novartis Pharmaceuticals Corp.
Action is expected by the FDA in the second quarter of 2014, according to the release.
Injected subcutaneously, omalizumab is intended for patients aged 12 years and older with moderate to severe persistent allergic asthma whose symptoms are uncontrolled by inhaled steroids.
Some patients receiving omalizumab experienced anaphylaxis, according to the release. Patients assigned omalizumab reported more cancers, including breast, skin, prostate and parotid, than those not assigned the drug during clinical studies.
The most common side effects in patients assigned omalizumab compared with placebo were joint pain, general pain, leg pain, fatigue, dizziness, fractures, arm pain, itching, skin inflammation and earache.
“We are pleased that the FDA has filed our application for Xolair for chronic idiopathic urticaria,” Hal Barron, MD, chief medical officer and head of global product development, Genentech, said in the release. “We hope we can soon bring our medicine to people with this chronic form of hives.”