European Commission has granted marketing authorization in all 25 EU member states for the novel asthma therapy Xolair ( Omalizumab ).

Xolair offers a unique therapeutic approach by blocking the action of IgE, an underlying cause of symptoms in allergic disease.

" Xolair represents a real advance in the management of asthma, having shown long-term efficacy and safety," said Stephen Holgate of Southampton General Hospital, UK. " This approval provides a much-needed breakthrough in the fight against severe allergic asthma. It's exciting to know that we finally have a treatment approach that has the potential to transform the lives of those who have been previously debilitated by this condition and for whom previously we have had little to offer."

Patients with severe asthma are at greatest risk of hospitalization and death.
According to the World Health Organization ( WHO ), more than 12,000 deaths are linked to asthma in Western Europe every year.
Asthma affects an estimated 30 million people in Europe, with up to 90% experiencing allergic asthma and attacks often being triggered by environmental factors such as pollen, animal dander and dust mites.
Around 20% of people with asthma in Western Europe are classified as having severe disease, and within this group some continue to experience inadequately controlled symptoms despite taking the best available therapy.

Xolair is administered by injection under the skin every two or four weeks, and targets the IgE antibody which is a root cause of the inflammatory cascade of symptoms in diseases such as allergic asthma.
Clinical studies have shown that it significantly reduced the rate of asthma exacerbations and halved the rate of emergency medical visits in patients with severe persistent asthma.
Benefits were seen even in patients whose asthma was inadequately controlled despite using the best available therapy and who were, as a consequence, at increased risk of life-threatening attacks.

In Europe, Xolair is licensed as add-on therapy to improve asthma control in adults and adolescents ( aged 12 and above ) with severe persistent allergic asthma, who have the following, despite daily high-dose inhaled corticosteroids plus a long-acting inhaled beta2-agonist:

- 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

Xolair treatment should only be considered for patients with convincing IgE-mediated asthma.

Xolair was approved by the US Food and Drug Administration ( FDA ) in June 2003.
It has been prescribed to more than 52,000 patients worldwide following its approval, which includes other countries such as Australia, Brazil, Canada and Venezuela.
Xolair has been developed under an agreement between Novartis Pharma AG, Genentech and Tanox.

The use of Xolair is supported by a comprehensive program of more than 30 clinical trials involving a total of approximately 5,500 patients. These demonstrated Xolair's efficacy in controlling symptoms, reducing asthma exacerbations and the need for emergency medical treatment, and improving quality of life, even in patients with severe allergic asthma that was uncontrolled by existing medication. Recent long-term data have shown that effective control was maintained for more than three years with Xolair, and that patients experienced improvements in their lung function and reductions in the need for inhaled corticosteroids.

The potential benefits of anti-IgE therapy are already recognized in treatment guidelines such as those developed by the Global Initiative for Asthma ( GINA ). These recommend anti-IgE therapy as add-on treatment for patients with severe allergic asthma that is inadequately controlled by standard clinical options.

Source: Novartis, 2005


XagenaMedicine2005