EU approves Xolair for Urticaria - Novartis + Genentech
Novartis announced that the European Commission (EC) has on 6 March 2014 approved the use of 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 was based on positive and consistent results from three pivotal Phase III registration studies (ASTERIA I, ASTERIA II and GLACIAL) that involved nearly 1,000 patients with CSU not responding to H1-antihistamines. Xolair 300 mg met all primary and pre-specified secondary endpoints across these studies, which showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms.
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