CHMP recommends Xolair for Urticaria-Novartis

Novartis announced on 24 January 2014 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for 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 recommended dose is 300 mg by subcutaneous injection every four weeks.

The CHMP opinion 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 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. Quality of life was also significantly improved for patients treated with Xolair 300 mg across the Phase III study program.