Novartis granted FDA approval for Xolair

Novartis has received approval from the US Food and Drug Administration (FDA) for its Xolair skin condition treatment, the company announced yesterday (March 24th).

Chronic idiopathic urticaria (CIU) is an unpredictable skin condition that can prove debilitating and the drug – also known under its chemical name omalizumab – has been approved for use in adults and adolescents over the age of 12 who continue to display symptoms following H1-antihistamine treatment.

Key aspects of the condition include red, swollen, itchy and occasionally painful hives on the skin, which present spontaneously and continue to re-occur for more than six weeks. As many as two-fifths of patients also experience angioedema swelling in the deep layers of the skin.

The FDA approval follows two key phase III studies, ASTERIA I and II, which showed Xolair significantly improved hives and itching, clearing symptoms in many cases.

In 2003, Xolair was approved by the FDA for the treatment of persistent allergic asthma.