Updated on 6 March 2014
Singapore: European Commission (EC) has approved Novartis' Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. The approved dose is 300 mg by subcutaneous injection every four weeks.
"The EU approval of Xolairin CSU is truly exciting for patients with this chronic and debilitating skin disease," said David Epstein, Division Head of Novartis Pharmaceuticals. "With this new therapeutic option from our specialty dermatology portfolio, our aim is to help ensure that the up to 50 percent of patients who suffer from CSU and don't respond to approved doses of antihistamines have access to Xolairas quickly as possible in the EU."
At any given time, the prevalence of chronic urticaria (CU) is up to 1 percent of the world's population, and up to two thirds of these patients have CSU. CSU is also known as chronic idiopathic urticaria (CIU) in the US, and is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives or wheals on the skin that spontaneously present and reoccur for more than six weeks. Up to 40 percent of CSU patients also experience angioedema, a swelling in the deep layers of the skin.