|
|
BY OUR PHARMA CORRESPONDENT
5 August, 2005: Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending that the European Commission grant a marketing authorisation for Xolair (omalizumab).
The drug is a novel anti-IgE therapy indicated for the treatment of severe persistent allergic asthma, the company announced in a press statement.
"We believe that Xolair is one of the most significant advances in asthma treatment in the last 15 years. It offers the potential for effective control of even very severe disease with an injection once or twice a month,'' the statement quoted.
Xolair will be the first humanised antibody to be approved for the treatment of asthma in Europe, and represents an innovative approach to controlling the disease. Unlike other asthma therapies, Xolair is given by injection every two or four weeks and is designed to block the action of the IgE antibody, a root cause of the inflammatory cascade in patients with diseases such as allergic asthma. By targeting the underlying mechanism of the disease, Xolair has the potential to prevent the onset of serious and potentially debilitating symptoms such as wheezing and shortness of breath, even in severely-affected patients.
Asthma affects an estimated 30 million people in Europe, according to estimates. Around 18% of people with asthma in Western Europe are classified as having severe disease, and within this group a minority continues to experience inadequately controlled symptoms despite taking the best available therapy.
Patients with severe asthma are at greatest risk of hospitalisation and death due to asthma. Hospital admission for asthma increases the risk of dying from the disease 10-fold, and according to the World Health Organization, in 2002 there were 12,000 deaths due to asthma in Western Europe. European patients with severe persistent asthma will now have an additional treatment option available to help address their unmet medical need.
Xolair submission was supported by more than 30 clinical trials involving a total of around 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. For example, the results of one of these clinical studies showed that the addition of Xolair to the best available therapy significantly reduced the number of severe asthma exacerbations (or 'attacks') and almost halved the rate of emergency medical visits.1 Xolair was found to be generally well-tolerated.
The file for approval of Xolair was submitted to European health authorities in June 2004, and the CHMP adopted a positive opinion following its meeting on July 26-28, 2005. The decision opens the way for approval later this year, after which the product will be launched in the first EU countries.
If approved by the European Commission, Xolair will be indicated as add-on therapy to improve asthma control in adult and adolescent patients (12 years of age and above) with severe persistent allergic asthma, who had 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 is already approved in nine countries including the US, where it was approved by the Food and Drug Administration (FDA) in June 2003. As of 30 June 2005 it had been prescribed to more than 45,000 patients. Other countries where it is approved are Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela. Xolair has been developed under an agreement between Novartis Pharma AG, Genentech, Inc., and Tanox, Inc.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world.
BY OUR PHARMA CORRESPONDENT
|
