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Anthony Cole may soon breathe more easily if the Food and Drug Administration does as expected Friday and approves a radically new therapy for allergic asthma.
Cole and an estimated half-million others with moderate to severe allergic asthma may just be the first wave of people to benefit from the new drug, doctors say.
Called Xolair (ZO-lare), it may eventually be a mainstay for people with the whole dismal spectrum of severe allergic ailments, from hay fever to eczema, from food allergies to life-threatening bee stings.
''This is really revolutionary,'' says Giovanni Della Cioppa of New Jersey-based Novartis, which, with partners Genentech Inc. of South San Francisco and Tanox Inc. of Houston developed the drug. They are preparing to start selling Xolair later this summer.
In May, an FDA advisory committee unanimously recommended approval for people with moderate to severe asthma who aren't being helped by other drugs. FDA rarely rejects an advisory committee's recommendation.
Controlled studies involving more than 6,000 people found that one or two monthly Xolair shots cut the number of asthma attacks in half, even when patients cut down on the dosage of their other medications. About twice as many Xolair patients were able to stop taking inhaled steroids than people in the study taking a placebo.
''One shot can eliminate five or six medications right away,'' says William Berger of Mission Viejo, Calif., an investigator in a Xolair trial and president of the American College of Allergy and Immunology. The drug appears to be safe, he says, without unusual side effects.
Della Cioppa says hay fever research is underway, and new studies are being planned for children with allergic asthma and people with peanut allergies. But Xolair's first real-world test will come in adults and adolescents with allergic asthma.
Increase in asthma sufferers
Doctors say improved asthma drugs are urgently needed. The number of people with asthma in the USA has grown from 6.7 million in 1980 to more than 17 million today. About 60% have allergic asthma. Each year, asthma sufferers account for 500,000 hospital admissions and 2 million emergency room visits. Asthma costs the economy an estimated $11 billion every year.
Analysts estimate that the market for Xolair hovers at about $1 billion, with the cost ranging from about $8,000 to $10,000 a year.
The drug will probably cut the overall cost of treating asthma, Berger says, but its expense will limit its use to patients with severe disease.
Cole, 25, is a perfect candidate for Xolair. Diagnosed at age 2, he was in and out of hospitals 120 times before he reached his teens. Continuous steroid treatments left him prone to colds and flu, which triggered asthma attacks. His airways were so inflamed that he was able to inhale only half the normal amount of air.
He was constantly short of breath, Cole says, and he always felt as if he had just run the 100-yard dash and was trying to catch his breath ''by breathing through a straw.''
Two years ago, Cole joined more than 1,000 other people in the ultimate studies of Xolair's effectiveness. Two injections a month, Cole says, enabled him to go from 13 to three drugs daily, and he was soon able to inhale about 85% the normal amount of air for someone his size.
''Every now or then I'll take a deep breath and I'll think 'I couldn't do this a couple of years ago,' '' Cole says.
How Xolair works
Xolair beats the immune system at its own game. It's a synthetic antibody, a custom-made version of the thousands of antibodies the immune system produces to knock out blood-borne microbes.
But Xolair is an antibody with an unusual target. It is specially designed to wipe out another antibody, IgE, the root cause of all allergic disease.
Researchers believe IgE once played a crucial role in immunity, by attacking parasites and preventing them from causing disease. In the developed world, parasites are rare, leaving IgE without a job to do. Idle IgE can spell trouble.
IgE settles on a type of white blood cell called the mast cell. Mast cells are loaded with histamine and other chemicals that promote inflammation to fight infections. But they also cause the symptoms of allergy: runny noses, watery eyes, skin rashes, shortness of breath.
In rare cases, IgE can set off an immune-system storm, anaphylactic shock, which can be fatal in minutes.
Xolair stops allergic reactions before they start, by latching onto IgE before it reaches the mast cell and preventing it from getting a toehold. The interlocking Y's are swept from the bloodstream and excreted with the rest of the body's waste.
''For the first time,'' Berger says, ''we're preventing asthma.''
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