Chronic spontaneous urticaria: Xolair is the first therapy approved in European Union
Novartis has announced that the European Commission ( EC ) has approved the use of Xolair ( Omalizumab ) as an add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent ( 12 years and above ) patients with inadequate response to H1-antihistamine treatment. The approved dose is 300 mg by subcutaneous injection every four weeks.
At any given time, the prevalence of chronic urticaria is up to 1% of the world's population, and up to two thirds of these patients have chronic spontaneous urticaria.
Chronic spontaneous urticaria is also known as chronic idiopathic urticaria 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 reoccur for more than six weeks. Up to 40% of chronic spontaneous urticaria patients also experience angioedema, a swelling in the deep layers of the skin.
The EU approval follows the Committee for Medicinal Products for Human Use ( CHMP ) positive opinion on Xolair, which was adopted based on positive and consistent results from three pivotal Phase 3 registration studies ( ASTERIA I, ASTERIA II and GLACIAL ) that involved nearly 1,000 patients with chronic spontaneous urticaria not responding to H1-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 3 study program. Negative effects of chronic spontaneous urticaria on quality of life may include sleep deprivation and psychological comorbidities such as depression and anxiety.
Results from the three pivotal registration studies for Xolair in chronic spontaneous urticaria were announced in 2013. Highlights from these studies that were previously reported include:
In all three phase 3 studies, a significant proportion of patients became either completely free of itch and hives or had their symptoms suppressed to minimal levels.
In the ASTERIA II study, 44% of patients receiving Xolair 300 mg were itch-and hive-free after 12 weeks of treatment.
In the ASTERIA I study, Xolair-treated patients experienced a rapid reduction in itch and hives as early as Week 1, with the therapeutic benefit sustained over 24 weeks of active treatment.
In the GLACIAL study, more than half of patients had failed multiple therapies including H1-antihistamines ( at up to four times the approved dose ) and H2-antihistamines and/or leukotriene receptor antagonists ( LTRAs ). Patient response in GLACIAL was similar to that seen in ASTERIA I and II, leading to elimination or suppression of symptoms to minimal levels within two weeks of the start of treatment, and sustained throughout the 24-week treatment period.
In the pivotal phase 3 studies, the incidence and severity of adverse events was similar between Xolair and placebo recipients. ( Xagena )
Omalizumab reduces clinical symptoms and signs of chronic idiopathic urticaria after H1-antihistamine therapy
Many patients with chronic idiopathic urticaria ( also called chronic spontaneous urticaria ) do not have a response to therapy...