EMA/CHMP gives Novartis positive opinion for Xolair; negative opinion on RLX030 to be appealed

TheCommittee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given Swiss drug major Novartis (NOVN: VX) a positive opinion for the use of Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU), a debilitating form of hives and chronic itch.

Xolair is being jointly developed by Novartis and Roche (ROG: SIX) subsidiary Genentech for CSU. The recommended dose in adult and adolescent patients 12 years and above with inadequate response to H1 antihistamines is 300 mg by subcutaneous injection every four weeks. Xolair showed consistent high efficacy across three Phase III CSU studies in results released last year. 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.

Positive results for CSU patients