MANILA, Philippines?The Bureau of Food and Drugs (BFAD) has approved the breakthrough drug omalizumab for the treatment of people 12 years of age and above who have moderate to severe persistent allergic asthma. Many experts consider omalizumab to be one of the most significant advances in asthma treatment in the last 15 years.

A prescription medicine given by injection, omalizumab is clinically proven to reduce the number of asthma attacks (exacerbations) and emergency medical visits in adolescents and adults with allergic asthma who have an IgE level between 30 and 700 IU/mL and whose symptoms are inadequately controlled with inhaled corticosteroids. Omalizumab has been shown to be beneficial to patients whose asthma was inadequately controlled even with the best available therapy and who were, as a consequence, at increased risk of life-threatening asthma attacks.

Asthma affects the respiratory system (the airways, lungs and muscles used to move air in and out of the body). Its symptoms not only affect breathing but also a person?s lifestyle or the simple tasks of daily living. These include shortness of breath, wheezing, tightness in the chest and coughing.

Most common type

Allergic asthma is the most common type of asthma. It is triggered by allergens in the air, such as cockroaches, dust mites, mold and pet dander (small scales shed from animal skin, hair or feather). A simple skin or blood test will confirm whether a person is suffering from allergic asthma.

IgE (immunoglobulin E) is a type of antibody produced by the body, which is thought to play a major role in asthma. When a person with asthma is exposed to allergens, his or her IgE binds to these allergens and triggers the release of chemicals that can cause airway constriction and inflammation, which can lead to an asthma attack.

Reducing IgE has been shown to be effective in asthma treatment. The potential benefits of anti-IgE therapy are already recognized in treatment guidelines such as those developed by the Global Initiative for Asthma (Gina). These guidelines recommend anti-IgE therapy as an add-on treatment for patients with severe allergic asthma inadequately controlled by standard clinical options.

Important breakthrough

?BFAD approval of omalizumab is an important breakthrough for patients unable to control their asthma despite the wide range of therapies currently available,? said Peter Goldschmidt, president and CEO, Novartis Healthcare Philippines.

?Finally, Filipino doctors have a new management option for difficult-to-treat asthmatic patients. The steroid-sparing potential is clearly seen in this scenario,? said Dr Daniel Tan, chief of the Pulmonology Section at Lourdes Hospital. ?Studies [on omalizumab] I have reviewed are very encouraging.?

?With its proven long-term efficacy and safety, omalizumab represents a real advance in asthma management,? said Dr. Francis Domingo, chief scientific officer, Novartis Healthcare Philippines. ?Finally, a breakthrough treatment is now available to improve the quality of life of patients who have long suffered from severe allergic asthma and for whom previously we have had little to offer.?

Patients with severe asthma are at greatest risk of hospitalization and death. According to the World Health Organization, 300 million people around the world suffer from asthma. In 2005, over a quarter of a million people died of asthma.

Omalizumab is a prescription medicine and should only be taken upon your doctor's advice.