Xolair (Omalizumab) shows promise in treating allergic asthma inadequately controlled by inhaled corticosteroid

Data presented today at the American College of Allergy, Asthma & Immunology (ACAAI) show that Xolair (Omalizumab) for Subcutaneous Use significantly reduced asthma attacks in children aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids.

The study further defines the safety profile of Xolair in this patient population.

The Phase III study showed that children treated with Xolair demonstrated a 31% reduction in clinically significant asthma exacerbations compared to children treated with placebo at 24 weeks. After a year of treatment, children treated with Xolair suffered 43% fewer clinically significant asthma exacerbations than those receiving placebo.

Xolair is a biologic treatment currently approved for people 12 years of age and above with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. It is the only approved therapy which blocks IgE (immunoglobulin E), a major component of allergic asthma. Genentech, co-marketer of Xolair, plans to submit these data to the US Food and Drug Administration (FDA) seeking to expand the current labeled indication for Xolair.

"Asthma is a life-threatening disease that can have serious health consequences in children. There are many children whose allergic asthma symptoms are just not adequately controlled despite optimal dosing with standard of care inhaled corticosteroid treatment," said principal investigator Bob Lanier, MD, Medical Director of the North Texas Institute for Clinical trials and Clinical Professor of Pediatrics at the University of North Texas Health Science Center. "In the Phase III study, children treated with Xolair experienced significantly fewer asthma exacerbations, or worsening attacks."

Asthma is the leading serious chronic illness of children in the US, affecting an estimated nine million children under the age of 18; of these children, 2.5 million suffer from allergic asthma, the most common type overall. Allergic asthma causes airway obstruction and inflammation, and can be triggered by allergens such as dust mites, pet dander, mold and cockroaches.

Among children aged five to 17, asthma is a leading cause of school absenteeism from a chronic illness, accounting for an annual loss of more than 12.8 million school days, and is the third leading cause of hospitalization for children under the age of 15.

Phase III Xolair Pediatric Study Results

The pivotal Phase III double-blind, randomized placebo-controlled study evaluated children aged six through 11 with moderate-to-severe allergic asthma uncontrolled despite inhaled corticosteroid (ICS) therapy. For eight weeks, ICS doses were optimized and baseline measures established in all study participants; 628 children still symptomatic after reaching optimized ICS dosing were randomized to receive add-on Xolair therapy or placebo. The study comprised a 24-week fixed-dose ICS phase, followed by a 28-week phase in which ICS doses could be reduced, and a 16-week safety follow-up period.

The study met its primary endpoint with Xolair-treated patients demonstrating a 31% reduction in clinically significant asthma exacerbations compared to patients treated with placebo at 24 weeks. The study also showed further support of the safety profile in a pediatric population aged six through 11. Adverse events were similar between groups and most (91%) were mild or moderate, with the most common being nasopharyngitis, sinusitis and upper respiratory tract infection. Two patients who were treated with Xolair withdrew from the study due to headache or bronchitis.

"We're encouraged by the Phase III clinical results that showed Xolair significantly reduced asthma exacerbations in children whose symptoms cannot be controlled with standard therapy," said John J. Orloff, MD, Head of US Medical and Drug Regulatory Affairs, North America at Novartis Pharmaceuticals Corporation. "Xolair represents a potentially important new approach to treating pediatric patients aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids."

Results from the trial were first presented at the European Respiratory Society Annual Congress in October 2008.

Xolair (Omalizumab) for Subcutaneous Use is a humanized monoclonal antibody for moderate-to-severe allergic asthma and the only approved therapy which blocks IgE (immunoglobulin E), a major component of allergic asthma. Xolair is indicated for adults and adolescents (12 years of age and above) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.

Xolair should always be injected in a doctor's office. Patients should read the Medication Guide before starting Xolair treatment and before each and every treatment.

A severe allergic reaction called anaphylaxis has happened in some patients after they received Xolair. Anaphylaxis is a life-threatening condition. Seek emergency medical treatment right away if symptoms occur. Signs and symptoms of anaphylaxis include:

• wheezing, shortness of breath, cough, chest tightness, or trouble breathing
• low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
• flushing, itching, hives, or feeling warm
• swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing  

Patients should not receive Xolair if they have ever had an allergic reaction to a Xolair injection. Patients should not use Xolair if they are allergic to any of its ingredients.

In clinical studies 0.5% of patients receiving Xolair developed cancer, compared to 0.2% of patients receiving placebo injections.

In clinical studies, the most common side effects in patients receiving Xolair included injection-site reactions (45%), viral infections (23%), upper respiratory tract infection (20%), sinus infection (16%), headache (15%), and sore throat (11%).

Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks. It is not a substitute for the medicines patients are already taking. Patients should not change or stop taking any of their other asthma medicines unless their doctor tells them to do so. Patients may not see an immediate improvement in their asthma when beginning Xolair therapy.

Please see Prescribing Information and the Medication Guide on www.Xolair.com for additional important information.

Xolair is co-marketed in the United States by Genentech, Inc. and Novartis Pharmaceuticals Corporation. Xolair was approved by the US FDA in June 2003 and is now available in 56 countries worldwide.