Novartis’ novel asthma therapy Xolair (omalizumab) has been approved for use in UK patients, following a green light from the European Medicines Agency earlier this year [[27/10/05h]].

Xolair is now available in the UK as an add-on therapy for patients with severe, persistent allergic asthma that is difficult to control with the best available treatments, thereby providing a new hope for those at increased risk of hospitalisation, Novartis claims.

Representing the first biologic to be cleared for the treatment of asthma, the drug works unlike any other marketed therapy, blocking antibodies that play a crucial role in the inflammatory cascade associated with the condition. Studies with over 4,300 patients demonstrate that Xolair significantly cuts the rate of asthma attacks, almost halves emergency visits and improves quality of life.

"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," commented Professor Stephen Holgate, lead clinical investigator and Clinical Professor of Immunopharmacology at the University of Southampton.

The news was welcomed by patient groups across the UK, which has one of the highest hospital admission and mortality rates for asthma in Europe, Novartis noted. Affecting 5.2 million people, the disease kills more than 1,400 people and leads to 69,000 hospital admissions in the UK every year. Almost 20% of people with asthma in the UK have severe, persistent disease, which is associated with a greater risk of hospitalisation and death, and accounts for almost half of the £889 million costs associated with asthma.

The agent, which was developed with Genentech and Tanox, obtained its first regulatory nod in the USA in June 2003 [[23/06/03b]], and has since been licensed in several countries including Australia, Brazil, Canada and New Zealand.

In the USA, the drug has enjoyed strong growth since it hit the market, though a slowdown was observed during the third quarter of this year, which saw sales of $82 million [[11/10/05a]] compared to the $80 million booked for the preceeding period [[12/07/05a]]. Despite this, Genentech maintains that approval in Europe, as well as for additional indications, should see the drug attain blockbuster status in the future.