Novartis was granted by the European Commission marketing authorisation in all 25 EU member states for the novel asthma therapy Xolair (omalizumab), considered by many experts to be one of the most significant advances in the last 15 years for helping patients with asthma.
Xolair's unique mechanism of action addresses the need to provide patients with a new injectable treatment that effectively controls asthma attacks and symptoms that often remain uncontrolled with current therapies.
As the first monoclonal antibody to be approved for the treatment of asthma, Xolair offers a unique therapeutic approach by blocking the action of IgE, an underlying cause of symptoms in allergic disease. Xolair is expected to become available in the first European countries within the next few weeks, claims a company release.
"Xolair represents a real advance in the management of asthma, having shown long-term efficacy and safety. 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," said professor Stephen Holgate of Southampton General Hospital, UK.
"We believe Xolair is one of the most significant advances in asthma treatment in the last 15 years and are pleased that patients in Europe will now be able to benefit from this highly innovative therapy. Novartis is proud to bring a medicine to the European markets that offers the potential for effective control of asthma attacks and symptoms in even patients with the most severe disease, where patients have been at significant risk of asthma exacerbations, hospitalisation and death," said Joerg Reinhardt, global head of development Novartis Pharma AG.
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.
Patients with severe asthma are at greatest risk of hospitalisation and death. According to the World Health Organisation, 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.