Xolair - First in Class Treatment Launched in UK for Severe, Uncontrolled Asthma

  BASEL , Switzerland , November 7/PRNewswire/ --

A New Approach to Targeting the Cause of Attacks in Severe, Allergic Asthma

Xolair(R) (omalizumab), a novel treatment for severe persistent allergic asthma, has been approved for use in the UK . It provides a new opportunity for people whose asthma can not be controlled with standard therapy and are at increased risk of hospitalisation(1,2). Omalizumab, the first targeted anti-IgE monoclonal antibody therapy to be approved in asthma, significantly decreases severe asthma attacks, almost halves emergency visits to doctors and hospitals and improves quality of life(3).

Unlike other therapies, omalizumab is designed to block the action of the IgE antibody, a factor in the inflammatory cascade associated with allergic asthma and is given by injection every two or four weeks. Omalizumab is available as an add-on treatment for patients with severe, persistent allergic asthma that cannot be controlled despite best available therapy.

"This really is a breakthrough for the treatment of difficult to control asthma, where patients can be at significant risk of asthma-related death and regular hospital admission. We finally have a treatment option which can offer effective long-term control, even in very severe disease," says Professor Stephen Holgate, lead clinical investigator and Clinical Professor of Immunopharmacology at the University of Southampton .

Studies involving 4,300 patients show that omalizumab significantly decreases asthma attacks, almost halves emergency visits and improves quality of life. Patients within European clinical trials were categorised with persistent, allergic asthma which remained inadequately-controlled despite the best conventional therapy, including inhaled corticosteroids, long-acting beta2-agonists and other controller medications(4). Long term studies have recently shown that effective control is maintained with omalizumab over a three year period(5).

The UK has one of the highest hospital admission and mortality rates for asthma in Europe (6). Asthma affects 5.2 million people in the UK and kills more than 1,400 people every year, whilst also leading to 69,000 annual hospital admissions(7). Over 50% of severe asthma is considered allergic with symptoms and attacks triggered by environmental allergens such as dog hair, pollen and dust mites(8). Almost 20 per cent of people with asthma in the UK have severe, persistent disease,(6) some of these people continue to experience inadequately controlled symptoms despite being administered best available therapy(9). Severe asthma is associated with a greater risk of hospitalisation and death, particularly if inadequately controlled (1,2). It also accounts for almost half of the GBP889 million costs associated with asthma, including hospitalisations, social security benefits and loss of earnings(6,7).

Omalizumab was approved for use in the US in June 2003 and has since been licensed in several countries including Australia , Brazil , Canada and New Zealand . Omalizumab treatment can be considered for patients who have been tested for IgE-mediated asthma i.e., asthma that is allergic. The benefits of anti-IgE therapy are already recognised within international treatment guidelines developed by the Global Initiative for Asthma (GINA), which recommend anti-IgE as add-on treatment for patients with severe allergic asthma that is inadequately controlled by standard clinical treatment options.

Omalizumab was approved by the EMEA on 27 October 2005 as add-on therapy to improve asthma control in adult and adolescent patients (12 years of age and above)(10). Omalizumab is recommended for those with severe persistent allergic asthma who despite daily high-dose inhaled corticosteroids plus a long-acting inhaled beta2-agonist are categorised with the following:

- a positive skin test or in vitro reactivity to a perennial aeroallergen

- reduced lung function (FEV1 <80%)

- frequent daytime symptoms or night-time awakenings

- multiple documented severe asthma exacerbations

References

1. Tough SC, Hessel PA, Ruff M, Green FH, Mitchell I, Butt JC. Features that distinguish those who die from asthma from community controls with asthma. J Asthma 1998;35:657-665.

2. Turner MO, Noertjojo K, Vedal S, Bai T, Crump S, Fitzgerald JM. Risk factors for near-fatal asthma. A case-control study in hospitalized patients with asthma. Am J Respir Crit Care Med 1998;157:1804-1809.

3. 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 Mar 2005

4. Bousquet J et al. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy Mar 2005: 60: 302-308.

5. Chung KF et al. Long-term asthma control with omalizumab, an anti-IgE monoclonal antibody in patients with severe allergic asthma. Poster (P417) presented at 15th European Respiratory Society Congress, Copenhagen , Denmark , 17-21 September 2005.

6. European Respiratory Society. European Lung White Book, 2003.

7. Where do we stand? Asthma in the UK , 2004:      www.asthma.org.uk/about/pdf/wheredowestand.pdf

8. Holt PG, Macaubas C, Stumbles PA, Sly PD. The role of allergy in the development of asthma. Nature 1999;402(Suppl.):B12-17.

9. Barnes PJ, Woolcock AJ. Difficult asthma. Eur Respir J. 1998 Nov;12(5):1209-18.

10. EMEA : European Agency for the Evaluation of Medicinal Products.

For general information about asthma and allergy, please contact:

Asthma UK : (Tel: +44-(0)8457-01-02-03 or email: info@asthma.org.uk

website: www.asthma.org.uk)

Allergy UK : (Tel: +44-(0)1322-619898 or email: info@allergyuk.org

website: www.allergyuk.org)

  (18/11/05)