MONDAY, June 23, 2003 (HealthDayNews) -- Revolutionary help is available for severely asthmatic people over age 12 who don't respond to traditional therapies, now that the U.S. Food and Drug Administration has approved Xolair (omalizumab) as the first biotech drug for allergy-related asthma.
Some 17 million American adults and children suffer from asthma, 60 percent of them from allergic asthma.
While the exact cause of allergic asthma is somewhat of a mystery, doctors have made significant inroads in figuring out what triggers an attack. When the body detects something it is allergic to, IgE antibodies send signals to "mast" cells all over the body to release histamines, prostaglandins, and other chemicals to counter the attacks.
In some cases, the antibodies react against substances that are completely benign, in which case, it's no longer the allergen that's the problem. It's the allergic reaction itself, which can be severe enough to kill a person.
Xolair prevents IgE antibodies from sending messages to the mast cells so these cells never get the signal to release the chemicals that cause the reaction.
In two six-month clinical trials, the drug proved effective in controlling the wheezing, breathlessness, and cough in severe asthmatics who did not respond to inhaled steroids, allergy injections, and other standard treatments. Participants in one study showed as many as one-third fewer asthma attacks while on the medication.
During the clinical trials, there was a very slight increase in the number of people who developed cancer while on the medication, prompting the FDA to ask the drug's manufacturer, Genentech, to investigate a possible connection. Also, three participants in the trials developed a life-threatening reaction to the drug itself; all eventually recovered.