Its Asmanex Twisthaler is the first once-a-day, inhaled corticosteroid medicine for asthma — the most common chronic condition among children — that can be taken by children as young as 4.
The Kenilworth-based company got FDA approval two years ago to sell the product as a maintenance treatment to prevent asthma flare-ups in adults and children 12 and older. The dosage for children aged 4 to 11, 110 micrograms, is half the adult dose.
Competing products are approved for children as young as 6, or must be taken more times a day.
Asthma is a chronic condition involving the respiratory system in which the airway occasionally constricts, becomes inflamed, and is lined with excessive amounts of mucus, often in response to one or more triggers. These episodes may be triggered by such things as exposure to an environmental stimulant (or allergen) such as cold air, warm air, moist air, exercise or exertion, or emotional stress. In children, the most common triggers are viral illnesses such as those that cause the common cold. This airway narrowing causes symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The airway constriction responds to bronchodilators. Between episodes, most patients feel well but can have mild symptoms and they may remain short of breath after exercise for longer periods of time than the unaffected individual. The symptoms of asthma, which can range from mild to life threatening, can usually be controlled with a combination of drugs and environmental changes.
Public attention in the developed world has recently focused on asthma because of its rapidly increasing prevalence, affecting up to one in four urban children.