http://www.cnn.com/2003/HEALTH/06/21/asthma.drug.ap/

FDA approves new asthma drug

Saturday, June 21, 2003 Posted: 1:16 PM EDT (1716 GMT)

WASHINGTON (AP) -- Patients with serious asthma caused by allergies are getting a new weapon to block the attacks, with approval of the drug Xolair by the Food and Drug Administration.

The drug, approved late Friday, is expensive, requiring monthly shots that will cost between $5,000 and $10,000 a year, depending on the dose. It is intended only for sufferers from serious allergic asthma who get no relief from standard medication.

Doctors have been anxiously awaiting it, however, because it works differently than any other asthma medicine, blocking an allergic reaction well before it triggers the hallmark gasping for air.

That same reaction is behind a range of allergic ailments, from hay fever to peanut allergy, that scientists hope Xolair one day will prove key to treating, too.

"This is radically new, it's not another antihistamine or another inhaler," said Dr. Bob Lanier of the University of North Texas Health Science Center, who led research on the drug for its three developers: Genentech Inc., Tanox Inc. and Novartis Pharmaceuticals.

This is radically new, it's not another antihistamine or another inhaler. -- Dr. Bob Lanier, University of North Texas

"It's the first of a new breed of bioengineered drugs that get to the root of the disease rather than just the symptoms," he said.

In one study, Xolair cut by one-third to one-half the number of asthma attacks suffered by patients whose disease isn't controlled by today's standard treatments. Many dramatically cut back or even eliminated inhaled steroids and other asthma medications.

But the FDA said its scrutiny of all studies of Xolair suggests it will help only about 15 percent of patients avoid an asthma attack.

A week after the first shot, "I was able to do something I'd never done in my life: Play with a dog," said Joe Wagner, 44, of Stockholm, New Jersey, a study participant. "It was like somebody turned a switch off."

The drug is generally safe, the FDA said. But three patients did suffer a life-threatening allergic reaction to the medicine itself.

Also, there appeared to be a very small increase in the number of Xolair-treated patients who had various forms of cancer -- half a percent compared with 0.2 percent of people given dummy injections. The FDA has asked the manufacturers to continue studying whether cancer is a real risk.

Some 17 million Americans have asthma, a chronic respiratory disease that causes recurring episodes of breathlessness, wheezing, chest tightness and coughing. Many patients require daily medication to control symptoms and prevent attacks. Every year, asthma kills 5,000 people and is responsible for nearly 2 million emergency room visits.

Allergic asthma is the most common form, affecting an estimated 7 million adults and 3 million children. Xolair is for those 12 and older with moderate to severe disease that isn't well-controlled by standard therapy.

Xolair will be available by prescription in late July, with a wholesale cost of $433 per injectable vial, according to Novartis. In studies, 60 percent of patients required one vial a month and the rest two; the dose is determined by patient size and degree of allergic reaction.

It's not clear how quickly insurance companies will cover Xolair, but despite its high cost the drug could actually save money for many patients, Lanier said. Add the numerous inhalers and pills that many patients require daily, plus emergency-room and doctor visits for asthma attacks, and the most severe patients today spend up to $25,000 a year.