Novartis’ new indication for Xolair approved in UK for chronic spontaneous urticaria

Swiss drug major Novartis (NOVN: VX) announced today that the European Commission has approved the use of Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent patients, who do not respond to the current mainstay of therapy, H1 antihistamines.

The approved dose in CSU is 300mg administered by subcutaneous injection once every four weeks. Prescribers are advised to periodically reassess the need for continued therapy. Clinical trial experience of treatment beyond six months in this indication is limited.

The EU approval follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion on Xolair in January, which was adopted based on positive and consistent results from three pivotal placebo-controlled clinical trials (ASTERIA I, ASTERIA II and GLACIAL) that involved nearly 1,000 patients with CSU not responding to H1 antihistamine treatment. Xolair 300mg met all primary and pre-specified secondary endpoints across these studies, which showed it 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.