Novartis reported positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding its chronic spontaneous urticaria (CSU) drug, Xolair. The committee approved the use of Xolair as an add-on therapy for CSU in patients 12 years and above with inadequate response to H1 antihistamines.
Xolair (omalizumab) is a targeted therapy that works by binding to immunoglobulin E (IgE). The drug suppresses histamine-induced skin reactions such as chronic itching and hives, possibly through its IgE reduction and following effects on cellular activation mechanisms. The drug showed consistency in high efficacy across three Phase III CSU studies. Novartis reported many patients who used Xolair in the trial experienced full eradication of symptoms compared to placebo.
Chronic spontaneous urticaria is a persistent and debilitating skin condition usually characterized by itch and painful hives. Symptoms are known to spontaneously occur and re-occur for as long as 6 weeks or more. Up to 40% of patients with CSU also experience swelling in the deep layers of the skin or angioedema. The disease is also known as chronic idiopathic urticaria (CIU).
Up to one percent of the total world population is affected with chronic urticaria (CU) at any given time, and up to two thirds of patients have CSU. Up to half of patients do not respond to approved antihistamine doses, at present the only licensed treatment for CSU in the EU.
Novartis Pharmaceutical Global Head of Development Tim Wright said, “This positive news from the CHMP brings us one step closer to providing an innovative therapeutic option from our specialty dermatology portfolio to people suffering from this chronic and debilitating disease… If approved, Xolair will be the first and only licensed therapy in the EU for up to 50% of CSU patients not responding to approved doses of antihistamines."
The positive CHMP opinion on Xolair was based on results from three pivotal Phase III registration studies (ASTERIA I, ASTERIA II, and GLACIAL) where the drug demonstrated consistent and positive performance in improving symptoms of CSU patients unable to respond to antihistamine treatments. Xolair is jointly developed by Novartis and Genentech and has received approval in Egypt, Turkey, El Salvador, and Guatemala.