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UK approval for severe asthma treatment Xolair

Published on 09/11/05 at 09:15am

Novartis has received UK approval for Xolair, its novel monoclonal antibody treatment for severe persistent allergic asthma.

The first drug in its class, Xolair (omalizumab) is given by injection every two or four weeks to treat the most serious cases of asthma.

It has to be taken in addition to standard asthma treatments and can only be prescribed by hospital consultants.

Xolair is indicated for adults and children over the age of 12. Before patients can take it they need to meet a series of criteria, such as showing a reduced lung function, and take a skin test.

The drug works by blocking the action of the antibody immunoglobulin E (IgE), which is responsible for triggering a series of chemical reactions that can lead to asthma attacks and symptoms.

Professor Stephen Holgate, lead clinical investigator and clinical professor of immunopharmacology at the University of Southampton said: "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."

The UK has one of the highest hospital admission and mortality rates for asthma in the UK. Clinical trials of Xolair involving 4,300 patients found it significantly reduced asthma attacks, almost halved visits to A&E and improved patients' quality of life.

Severe persistent asthma affects almost 20% of the UK's 5.2 million asthma patients, but is responsible for nearly half of the £889 million cost of the condition - more than half of severe asthma cases are thought to be the allergic form.

Martin Dockrell, Asthma UK's assistant director of policy and public affairs, said: "Although this treatment may only be suitable for a relatively small proportion of people with asthma, it will increase the treatment options for those whose asthma is particularly difficult to control."

Last year a report by patient group Asthma UK found the quality of life of many people with severe asthma was reduced to the point where they feared the next asthma attack would be their last.

NICE's appraisal of Xolair is ongoing with a decision expected next year and Asthma UK said it will be pressing the Institute to speed up the process so the drug can quickly be made more widely available.

Xolair was jointly developed by Novartis, Genentech and Tanox, receiving approval in the US in 2003. It will join asthma and COPD treatment Foradil in Novartis' respiratory disease portfolio.

Xolair is the first product in its class of anti-IgE monoclonal antibodies to be approved, but fortunes have been mixed for other targeted monoclonal antibody asthma therapies. Schering-Plough discontinued research into its monoclonal antibody asthma treatment reslizumab in 2002 when it was in phase II trials.

Meanwhile, GlaxoSmithKline is continuing research into mepolizumab, but it is far from being a high priority. It has been in phase II trials since 1998 and last year received an orphan drug designation from the EMEA as a treatment for hypereosinophilic syndrome, a condition where organs are damaged by the over-production of white blood cells.

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