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Asthma drug omalizumab approved for treatment of urticaria

The monoclonal antibody omalizumab (Xolair) has been approved by the European Commission as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents with inadequate response to H1 antihistamine treatment. Omalizumab is already indicated for severe allergic asthma.

The approved dose for CSU is 300mg given by subcutaneous injection once every four weeks; clinical trial experience beyond six months for this indication is limited. The condition — a persistent, debilitating form of chronic itch, hives and angioedema — is estimated to affect between 318,000 and 630,000 people in the UK at any given time, according to the manufacturer of omalizumab Novartis.

The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended approval of the add-on indication in January 2014.

According to the company, omalizumab is the first and only approved add-on therapy in the UK for CSU patients who have an inadequate response to H1 antihistamine treatment. Novartis claims that up to half of patients do not respond to licensed doses of H1 antihistamines, which, until now, were the only approved treatments for CSU.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11135574

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