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Novartis-Genentech’s Urticaria drug Xolair gets US FDA approval

The US Food and Drug Administration (FDA) has approved Novartis and Genentech's Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), an unpredictable and debilitating skin disease that is called as chronic spontaneous urticaria (CSU) outside of the US.


The company said that the new use is for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.

So far, H1-antihistamines have been the only approved therapy for CIU, with about 50% of patients having an inadequate response.

Genentech chief medical officer and head of Global Product Development Sandra Horning said chronic idiopathic urticaria can be difficult to manage because its causes are unknown, and other approved medicines aren’t effective enough for many patients.

"We are pleased to have Xolair as a new option for people with this serious skin condition," Horning said.

The company said that CIU / CSU is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives on the skin that spontaneously present and re-occur for over six weeks.

Xolair, an injectable prescription medicine, is jointly developed by Genentech and Novartis Pharma and is co-promoted in the US with Novartis Pharmaceuticals Corporation.

It is the first biologic medicine and first medicine approved by the US FDA for CIU since non-sedating H1-antihistamines.

The efficacy and safety profile of the drug for the treatment of CIU was assessed in two clinical trials called ASTERIA I and ASTERIA II.

In these trials, patients 12 to 75 years old were given doses of Xolair at 150mg, 300mg or placebo5.

Most common side effects in patients treated with Xolair were nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

Image: Novartis headquarters in Basel, Germany. Photo courtesy of Andrew.