FRIMLEY, England, August 31 /PRNewswire/ --
- Clinicians Welcome Drug Watchdog's Decision to Grant NHS Patients Access to Xolair(R) (Omalizumab) for Severe, Persistent Allergic Asthma.
Novartis today welcomes the decision made by the National Institute for Health and Clinical Excellence (NICE) to recommend the use of Xolair(R) (omalizumab) in adolescents (12 years of age and above) and adults with severe, persistent allergic asthma(1). Evidence shows that, when used as add-on treatment, Xolair can significantly improve symptom contro(l2) and quality of life in those patients in whom best current management has failed.
Xolair is the first drug shown to stabilise severe allergic asthma in a significant proportion of patients by tackling its root cause. Xolair blocks the body reacting to inhaled particles such as pollen, cat dander and house-dust mite droppings that cause the symptoms associated with severe allergic asthma(3,4). Through the alleviation of the severe symptoms that can be associated with asthma deaths, patients benefit from a reduced risk of severe exacerbations and the need for emergency treatment.(2)
Asthma is a chronic, inflammatory lung disease which kills approximately 1,400 people every year (one every six hours)(5), whilst also leading to 71,000 annual hospital admissions.(6) Up to 50% of severe asthma is classified as allergic(7) and approximately 20% of people with asthma are classified as having a severe, persistent asthma(8) meaning their symptoms are present continuously during the day and frequently at night, and their level of physical activity is significantly reduced(9).
Dr Robert Niven, Respiratory Consultant commented: "Xolair offers hope for patients with severe, persistent allergic asthma. In this small but important group with poorly controlled disease, it is clinically proven to significantly reduce asthma deteriorations and significantly improve quality of life. Before Xolair was available, clinicians were very limited in what they could do to control symptoms in these patients other than prescribe high doses of conventional medications including oral steroids".
NICE recommend that patients who are eligible for Xolair therapy must be diagnosed with severe, persistent allergic asthma and have severe, unstable disease. Specifically they should have experienced either two or more severe exacerbations of asthma requiring hospital admission within the previous year, or three or more severe exacerbations of asthma within the previous year, at least one of which required admission to hospital, and a further two which required treatment or monitoring in excess of the patient's usual regimen, in an accident and emergency unit. NICE have also stated that each patient must also have had a full trial of and documented compliance with standard treatment. If relevant, patients must also stop smoking.(1)
Subhanu Saxena, Chief Executive Officer, Novartis UK said: "We welcome the NICE recommendation to make Xolair available to patients with such severe asthma. As a result of today's decision, we hope that more patients will have access to Xolair to alleviate their asthma symptoms and experience a better quality of life."
Xolair was developed under an agreement between Novartis Pharma AG, Genetech, Inc., and Tanox, Inc. and launched in the UK in 2005. This decision on the use of Xolair is expected to be issued by NICE to the NHS in England and Wales within the next six weeks. It will then form the guidance for clinical practice within the NHS.
Notes to Editors:
About the NICE Guidance
Xolair add-on therapy should only be initiated if the patient fulfils the criteria of severe unstable allergic asthma:
- Clinical confirmation of allergic (IgE mediated) asthma
- Either two or more severe exacerbations of asthma requiring hospital admission within the previous year, or three or more severe exacerbations of asthma within the previous year, at least one of which required admission to hospital, and a further two which required treatment or monitoring in excess of the patient's usual regimen, in an accident and emergency unit.
- A full trial and documented compliance with inhaled high-dose corticosteroids and long acting Beta-2 agonists in addition to leukotriene receptor antagonists, theophyllines, oral corticosteroids and Beta-2 agonist tablets and smoking cessation where applicable.
Xolair add-on therapy should be initiated and monitored by a physician experienced in both allergy and respiratory medicine in a specialist centre
Xolair add-on therapy should be discontinued at 16 weeks in patients who have not shown an adequate response to therapy. Response to treatment should be defined on the basis of a full clinical assessment, comprising:
- Degree of asthma control, quality of life, control of exacerbations
- Global evaluation of treatment effectiveness as assessed by physician
- Reported improvement in daily symptoms and in measurements of peak expiratory flow rate (a test which measures how much air can be expelled from the lungs in one exhalation)
- Reduction in unplanned consultations for asthmai
Full details of the NICE guidance can be accessed via the NICE website at http://www.nice.org.uk
About Xolair(R) (omalizumab)
Xolair is a humanised monoclonal antibody that targets the root cause of allergic asthma by blocking the action of IgE, the molecule responsible for initiating the inflammatory response in allergic asthma. Eligible patients must have a positive skin or blood test for a perennial allergen on FEV < 80% as well as frequent day time symptoms and/or night time awakenings. It is administered as a subcutaneous injection every two to four weeks, in doses of 150-375 mg. Doses and frequency are determined by levels of total IgE in the blood, measured before the start of treatment, and will vary according to patient body weight (kg.)(3)
More than 30 clinical studies have been undertaken with Xolair and the clinical development programme is still ongoing. Throughout clinical trials, Xolair has shown consistent benefit for adolescent and adult patients with severe, persistent allergic asthma. Clinical research shows that adding Xolair to the best available therapy significantly reduces the rate of emergency visits and halves the number of severe asthma exacerbations. Xolair also improves asthma symptoms and asthma-related quality of life.(2)
About Asthma
- Asthma is a chronic, inflammatory lung disease that is often triggered by allergies and is characterised by airway obstruction, resulting in the symptoms of chest tightness, wheezing and coughing.
- Asthma impacts 5.2 million people in the UK(2). Up to 50% of asthma is classified as allergic(7), and up to 20% of people with asthma are classified as having severe, persistent asthma.(8)
- Severe, persistent asthma is characterised as the presence of one or more of the following, despite an optimal level of asthma therapy:
- Continous daytime symptoms
- Limited physical activity during the day
- Frequent symptoms at night
- PEF or FEV1 lesser than or equal to 60% and PEF variability greater than or equal to 30%(9)
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
References:
(1) National Institute for Clinical Excellence. Final Appraisal Determination - Omalizumab for severe, persistent allergic asthma. Accessed 29 August 2007 - http://www.nice.org.uk
(2) Humbert. M et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy 2005: 60: 309-316
(3) Xolair SPC, May 2007.
(4) Asthma UK. Asthma triggers A-Z. Accessed 23 August 2007. http://www.asthma.org.uk/all_about_asthma/triggers_az/index.html
(5) Asthma UK. Key facts about asthma for journalists. Accessed August 15th 2007 http://www.asthma.org.uk/news_media/media_resources/for_1.html
(6) Patient UK. Acute severe asthma and status asthmaticus. Accessed 23 August 2007. http://www.patient.co.uk/showdoc/40002346
(7) The ENFUMOSA Study Group. The ENFUMOSA cross-sectional European multicentre study of the clinical phentotype of chronic severe asthma. Eur Respir J 2003;22:470-477
(8) European Respiratory Society. European Lung White Book, 2003.
(9) Global Initiative for Asthma (GINA). GINA workshop report: Global Strategy for Asthma Management and Prevention. Available at http://www.ginasthma.com
For media enquiries, please contact: Sally Irvine Novartis Pharmaceuticals, Tel: +44-(0)1276-698-145, Mobile: +44-(0)7966-118652, Fax: +44-(0)1276-692255, email: sally.irvine@pharma.novartis.com; Nick James Chandler Chicco Agency (CCA), Tel: +44-(0)207-632-1828, Mobile: +44-(0)7776-258990, Fax: +44-(0)207-632-1801, email: n.james@cca-uk.com
