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Xolair gains final NICE approval



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NICE is recommending Novartis’ asthma drug Xolair as a cost effective treatment for young children and adults with a severe form of the condition in England.

Novartis’ Xolair (omalizumab) is now recommended as an option for treating severe, persistent confirmed allergic immunoglobulin E (IgE)-mediated asthma in people aged six years and older.


Omalizumab (trade name Xolair, Roche/Genentech and Novartis) is a humanized antibody approved for patients 12 years and older with moderate to severe allergic asthmain the United States and with severe, persistent allergic asthma in many other countries. It has also been approved for pediatric patients 6 to 11 years old with severe, persistent allergic asthma in the European Union. Omalizumab’s cost is high, ranging from $6,000 to $24,000 a year and hence omalizumab is mainly prescribed for patients with severe, persistent asthma, which cannot be controlled even with high doses of corticosteroids.

Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Unlike an ordinary anti-IgE antibody, omalizumab does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast cells,basophils, and antigen-presenting dendritic cells. IgE is commonly involved in type I hypersensitivity, which manifests the most prevalent allergic diseases. It has been estimated that as high as 20 to 40% of the populations who live a western lifestyle in economically advanced countries are affected by allergy and seek medical help.[1] While allergy occurs more frequently in individuals with higher serum IgE levels, such a correlation is only statistical and not absolute. Some allergic individuals have very low serum IgE, and some people with very high IgE have no allergic problems.

Xolair received approval by the U.S. Food and Drug Administration (FDA) in 2003 for treating patients 12 years and older with moderate to severe allergic asthma. It has also received approval in many other countries for treating patients 12 years and older with severe, persistent allergic asthma. Xolair was approved by the European Union in 2009 for treating patients 6 to 12 years old with severe, persistent allergic asthma. Thus, the primary use of Xolair is for patients mostly with severe, persistent allergic asthma, uncontrollable with oral or injectable corticosteroids.[2] The efficacy is more evident among severe asthmatics than among those with moderately severe disease. The response rates among treated severe “allergic” asthma patients are 60-80% or higher, probably depending on the patient screening procedures used by the various clinical groups of different specialties. Because 30-40% of adult asthma cases are not related to allergy and unresponsive to Xolair, a reliable way to identify treatable patients has been a subject of considerable research interest. The primary benefits for the responding patients are reduced numbers of exacerbations, improved lung function, reduced numbers of emergency visits to the doctors, reduced days of hospitalization, and increased quality of life measurements. The other major benefit is that most responding patients can reduce or spare entirely the use of corticosteroids, which cause multiple serious side effects, when used at high doses for extended periods.

Due to the requirement for long-term administration and hence the high cost of a Xolair treatment regimen, and to the concern over long-term safety, Xolair treatment is not yet very common, especially in developing countries where medical funds are relatively scarce. Another barrier to Xolair’s wide use is its injectable dosage form, which requires the patient to visit a physician’s office or clinic every 2 to 4 weeks during treatment. In August 2010, the National Institute for Clinical Excellence (NICE) in the United Kingdom ruled that Xolair should not be prescribed on the National Health Service (NHS) to children under 12, causing widespread condemnation from asthma charities.[3] NICE concluded that the high costs of the compound, over £250 per vial, did not represent a sufficiently high increase in quality of life. Additionally, as IgE could be a natural defense against parasitic diseases, treatment is usually not recommended when living in environments where the presence of parasites is common.

The website reveals that 102 clinical trials on omalizumab on various clinical indications have been finished or are in progress as of June 23, 2012. Among those more than 70 are multi-center, placebo-controlled phase II or III trials.[4] The tested indications are in the areas of allergic asthma, perennial and seasonal allergic rhinitis, peanut allergy, latex allergy, atopic dermatitis,chronic urticaria, idiopathic anaphylaxis, mastocytosis, eosinophilic gastroenteritis, nasal polyposis, and others. The relatively recent clinical trial results, which indicate that omalizumab has excellent effects on patients with recalcitrant, antihistamine-resistant chronic idiopathic urticaria, including those cases of autoimmune cause,[5][6] have generated much excitement among dermatologists as well as patients affected by chronic urticaria. Omalizumab has also been studied in combination with allergen-based specificimmunotherapy (allergy shots) for the purpose of reducing anaphylactic reactions when receiving allergen immunizations and of accelerating immunization schedule and dosing, so as to achieve therapeutic effects in shorter treatment periods and in broader patient populations.[7][8][9]

While data from additional clinical trials are required for omalizumab to be reviewed by governmental regulatory bodies for approval for any of the new indications, the data from finished trials thus far indicate that omalizumab is efficacious and safe for treating various IgE-mediated allergic or non-allergic diseases

  2.  Davydov L (January 2005). “Omalizumab (Xolair) for treatment of asthma”. Am Fam Physician 71 (2): 341–2. PMID 15686303.
  3.  “Asthma drug ruling ‘nonsensical'”BBC News. August 12, 2010.
  5.  Saini S, Rosen KE, Hsieh HJ, Wong DA, Conner E, Kaplan A, Spector S, Maurer M (September 2011). “A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria”. J. Allergy Clin. Immunol. 128 (3): 567–73.e1. doi:10.1016/j.jaci.2011.06.010PMID 21762974.
  6.  Kaplan AP, Joseph K, Maykut RJ, Geba GP, Zeldin RK (September 2008). “Treatment of chronic autoimmune urticaria with omalizumab”. J. Allergy Clin. Immunol. 122 (3): 569–73. doi:10.1016/j.jaci.2008.07.006PMID 18774392.
  7.  Casale TB, Busse WW, Kline JN, Ballas ZK, Moss MH, Townley RG, Mokhtarani M, Seyfert-Margolis V, Asare A, Bateman K, Deniz Y (January 2006). “Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis”. J. Allergy Clin. Immunol. 117 (1): 134–40. doi:10.1016/j.jaci.2005.09.036PMID 16387596.
  8.  Kopp MV, Hamelmann E, Zielen S, Kamin W, Bergmann KC, Sieder C, Stenglein S, Seyfried S, Wahn U; DUAL study group (October 2008). “Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma”. Clin Exp Allergy 39 (2): 271–9. doi:10.1111/j.1365-2222.2008.03121.x.PMID 19016798.
  9.  Massanari M, Nelson H, Casale T, Busse W, Kianifard F, Geba GP, Zeldin RK (February 2010). “Effect of pretreatment with omalizumab on the tolerability of specific immunotherapy in allergic asthma”. J. Allergy Clin. Immunol. 125 (2): 383–9.doi:10.1016/j.jaci.2009.11.022PMID 20159249.

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