FDA Approves Novartis' Xolair For Chronic Idiopathic Urticaria
By Cyndi Root
Novartis announced in a press release that the Food and Drug Administration (FDA) has approved Xolair (omalizumab). The treatment is for chronic idiopathic urticaria (CIU). The approval is for adult and adolescent CIU patients who have not responded to H1-antihistamine treatment. Before this approval, H1-antihistamines were the only approved therapy for CIU in the United States. David Epstein, Division Head of Novartis Pharmaceuticals said, "This approval from the FDA is great news for patients in the US suffering from CIU, a skin disease known as CSU in other parts of the world. Up to 50% of patients do not respond to approved doses of H1-antihistamines.”
Chronic Spontaneous Urticaria
Chronic spontaneous urticaria (CIU) is urticaria that persists for more than six weeks. Urticaria, or chronic hives, are red or white raised welts of various sizes. Most episodes last less than six weeks but if they last longer than six weeks CIU is diagnosed. The cause of most hive cases is often unknown, however some cases arise due to autoimmune disorders like lupus. Over one million people have CIU, with women and people between the ages of 20 and 40 being the hardest hit.
FDA Approval
The FDA based its approval on the results of phase III studies, ASTERIA I and II. The enrollees in the study had previously been treated with H1-antihistamines with no success. Patients received Xolair 150 mg and 300 mg. The results showed that Xolair provided rapid itch relief, significantly improved hives, and in some cases cured the symptoms of CIU. The ASTERIA I study showed itch and hive reduction in the first week of treatment and sustained response over 24 weeks. The ASTERIA II study demonstrated that 44 percent of patients on the 300 mg dose were symptom free after12 weeks.
The GLACIAL study confirmed the ASTERIA studies with suppression in two weeks, sustained through 24 weeks. In all clinical studies including the GLACIAL study, 34-44 percent of patients became free of itching and hives and 52-66 percent improved symptomatically. Adverse events were similar between Xolair and a placebo. Side effects may include depression, anxiety, and sleep deprivation.
Xolair is approved in Europe, Egypt, Turkey, and six other countries. More than 20 countries are reviewing the drug for safety and efficacy. Xolair, FDA approved in 2003, is a joint project with Novartis and Genentech, Inc., the drug’s first sponsor.