The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of Novartis' 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.
At any given time, the prevalence of chronic urticaria (CU) is up to one per cent of the world's population, and up to two thirds of these patients have CSU. CSU is also known as chronic idiopathic urticaria (CIU) in the US, and is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives or wheals on the skin that spontaneously present and re-occur for more than six weeks. Up to 40 per cent of CSU patients also experience angioedema, a swelling in the deep layers of the skin.
"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," said Tim Wright, global head of Development, Novartis Pharmaceuticals. "If approved, Xolair will be the first and only licensed therapy in the EU for up to 50 per cent of CSU patients not responding to approved doses of antihistamines."
The European Commission generally follows the recommendations of the CHMP and usually issues its final decision within two months of the CHMP opinion.
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 programme. Negative effects of CSU on quality of life may include sleep deprivation and psychological comorbidities such as depression and anxiety. In these studies, the incidence and severity of adverse events (AEs) was similar between Xolair and placebo recipients.
Xolair has already been approved for the treatment of CSU in four countries: Egypt, Turkey, Guatemala and El Salvador. Regulatory reviews are currently ongoing in more than 20 countries, including the US, Canada, Australia and Switzerland. Xolair is being jointly developed by Novartis and Genentech, Inc. for CSU.
Three pivotal phase III studies, ASTERIA I, ASTERIA II and GLACIAL, evaluated the efficacy and safety of Xolair in nearly 1,000 CSU patients not responding to antihistamines.
Xolair is a targeted therapy that binds to immunoglobulin E (IgE). Xolair suppresses histamine-induced skin reactions, probably through its reduction of IgE and downstream effects on cellular activation mechanisms. Research is ongoing to understand the mechanism of action of Xolair in CSU, which could lead to a deeper understanding of how the disease develops.
Xolair is currently approved for the treatment of CSU in four countries. It is approved for the treatment of moderate to severe persistent allergic asthma in more than 90 countries, including the US since 2003 and the EU since 2005 and has over 400,000 patient years of exposure. In the EU, it is approved for the treatment of severe persistent allergic asthma in children (aged six and above), adolescents and adults. In addition, a liquid formulation of Xolair in pre-filled syringes has been approved in the EU and launched in most European countries. In the US, Xolair for subcutaneous use in appropriate allergic asthma patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech, Inc.
Novartis is committed to developing innovative, life-changing specialty dermatology therapies, redefining treatment paradigms and transforming patient care in severe skin diseases where there are remaining high unmet medical needs. The Novartis specialty dermatology portfolio includes two targeted products with Phase III registration studies completed, Xolair for CSU and secukinumab (AIN457) for moderate-to-severe plaque psoriasis.
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