Omalizumab, sold under the brand name Xolair among others, is an injectable medication to treat severe persistent allergic forms of asthma, nasal polyps, urticaria (hives),[10][11] and immunoglobulin E-mediated food allergy.
[5] Omalizumab is used to treat people with severe, persistent allergic asthma that is not controlled with oral or injectable corticosteroids.
Such a treatment scheme is consistent with the widely adopted guidelines for the management and prevention of asthma, issued by Global Initiative of Asthma (GINA), which was a medical guidelines organization launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, US, and the World Health Organization.
[16] A 2014 Cochrane review found that omalizumab was effective in reducing exacerbations and hospitalisations related to asthma when used as an adjunct to steroids.
[medical citation needed] At the end of culturing, the IgG contained in the medium is purified by an affinity-column using Protein A as the adsorbent, followed by chromatography steps, and finally concentrated by UF/DF (paired ultra filtration/depth filtration).
[24] This is now thought to be the fundamental mechanism for omalizumab's effects on allergic and non-allergic diseases involving mast cell degranulation.
Many investigators have identified or elucidated a host of pharmacological effects, which help bring down the inflammatory status in omalizumab-treated patients.
These diseases include atopic dermatitis, various subtypes of physical urticaria (solar, cold-induced, local heat-induced, or delayed pressure-induced), and a spectrum of relatively less prevalent allergic or non-allergic diseases or conditions, such as allergic bronchopulmonary aspergillosis,[31] cutaneous or systemic mastocytosis, bee venom sensitivity (anaphylaxis),[32] idiopathic anaphylaxis, eosinophil-associated gastrointestinal disorder, bullous pemphigoid,[33] interstitial cystitis,[34] nasal polyps, and idiopathic angioedema.
Omalizumab's primary adverse effect is anaphylaxis (a life-threatening systemic allergic reaction), with a rate of occurrence of 1 to 2 patients per 1,000.
[17] Limited studies are available to confirm whether omalizumab increases the risk of developing cardiovascular (CV) or cerebrovascular disease (CBV).
[42][43] Additional multi-national, longitudinal studies with increased subject numbers are required to provide further clarification into the relationship and clinical significance between omalizumab and CV/CBV disease.
This approval of IND for an anti-IgE antibody for the first time was regarded a brave demonstration of professionalism for both the FDA officials and the Tanox/Ciba-Geigy team.
The scientists participating in the pre-IND discussion comprehended that an ordinary anti-IgE antibody (i.e., one without the set of the binding specificity of CGP51901) would invariably activate mast cells and basophils and cause anaphylactic shock and probably deaths among injected persons.
Notwithstanding this concern, they came to the same view that based on the presented scientific data, CGP51901 should have an absolutely required clean distinction from an ordinary anti-IgE antibody in this regard.
[61] In October 2005, EMA issued the marketing authorization for omalizumab for the therapeutic indication of obstructive airway disease to Novartis.
[64] However, in March 2013, NICE issued "final draft guidance" about the allowance of omalizumab, recommending the medication as an option for treating severe, persistent allergic asthma in adults, adolescents and children following additional analyses and submission of a "patient access scheme" by Novartis, the manufacturer.