Novartis is seeking European approval for Xolair, a novel monoclonal antibody drug for the treatment of severe persistent allergy-induced asthma.

Xolair (omalizumab) is the first non-steroidal therapy proven to have a major anti-inflammatory effect in allergic asthma. It works by blocking the action of the antibody IgE, which is responsible for triggering a series of chemical reactions that can lead to asthma attacks and symptoms.

Xolair must be administered by injection in hospital but lasts for two to four weeks, benefiting patients who remain inadequately controlled despite use of inhaled corticosteroids and long-acting beta-2 agonists.

A spokesperson for Novartis said Xolair would be given to  "a very select group of patients who have got very severe asthma, who get hospitalised continuously and their inhaler medication is not enough to control their symptoms."

If approved, Novartis expect to launch Xolair in the UK in the fourth quarter of 2005. The drug's exact cost will be negotiated nearer to its launch date but Novartis expect it to cost around £5,000 per patient per year, a price reflecting its high production costs and small patient population. Novartis estimates that around 250,000 people have uncontrollable allergic asthma in Europe.

The drug's novel action and high price tag has already brought it to NICE's attention, the Institute scheduled to finish its appraisal in May 2006.

Xolair was jointly developed by Novartis, Genentech and US biotech Tanox and was launched in the US in June 2003.

The EU submission is based on more than 30 clinical trials involving 5,500 patients. One of these clinical trials showed that patients taking Xolair had 60% fewer asthma attacks, and more had none (49.5% compared to 26.4%), than those on the best standard care alone.

The drug was generally well tolerated in the trials, but showed a small rise in patients developing cancer ­ 0.5% of patients against 0.2% of patients receiving a placebo, but there was no evidence linking the malignancies to the drug.

Novartis, Genentech and Tanox are seeking further indications for Xolair, which is currently in phase III clinical trials in paediatric allergic asthma patients and in phase II trials for use as a treatment for peanut allergy.

pharmaocus@pharmafile.co.uk