FDA Panel Backs Asthma Medication
A Food and Drug Administration advisory panel unanimously recommended Thursday that the agency approve Genentech Inc.’s drug Xolair, putting it on track to become the first biotechnology product to treat asthma.
Wall Street reacted eagerly, pushing Genentech’s stock to a 52-week high of $40.30 before it closed at $40.05, up $1.57 for the day on the New York Stock Exchange.
The FDA isn’t required to follow the recommendations of its advisors but often does.
“This is exactly the vote we were looking for,” said Genentech chief medical officer Susan Desmond-Hellman. South San Francisco-based Genentech, the world’s second-largest biotech company, expects the FDA to formally approve Xolair for sale by the end of June.
The company would market Xolair jointly in the U.S. with Swiss drug maker Novartis, and the two would share profit.
The 11-member FDA panel recommended approving Xolair for patients ages 12 to 65 whose asthma is caused by a year-round allergy and cannot be controlled by current steroid inhalers. About 500,000 patients with allergies to such things as pets and dust mites fall into that category, Genentech said.
Xolair is an injectable drug given once or twice a month.
Genentech and Novartis see potential for Xolair beyond asthma. The companies are testing the drug in hay fever patients with asthma and expect to begin a study in peanut allergy patients by the end of the year. They believe Xolair also could be a useful treatment for patients suffering from other food allergies or who are sensitive to substances such as latex.
Worldwide Xolair sales could reach $80 million in 2004 and rise to $750 million in 2008, said analyst Patrick Flanigan of Adams, Harkness & Hill.
But widespread use of Xolair could present a test to health insurers already under pressure to control drug spending. Analysts expect Xolair to cost $7,500 to $10,000 a year; Genentech hasn’t announced a price.
“If people with cancer can have coverage for expensive drugs, why can’t people with allergies?” said Marianne Frieri, director of allergy and immunology at Nassau University Medical Center in East Meadow, N.Y.
Genentech is seeking approval of the drug for patients ages 12 to 75 who have moderate to severe allergic asthma -- attacks of wheezing, coughing and shortness of breath -- despite conventional treatment with inhaled steroids.
Allergy is the most common cause of asthma but not the only one. About 45% of asthma patients age 12 and older suffer from the ailment because of allergies, according to Genentech.
Already there are signs that Genentech and Novartis will have to work hard to persuade insurers to sign off quickly on Xolair. “We will not be endorsing it right out of the gate,” said Robert Seidman, chief medical officer of WellPoint Health Networks Inc., parent of Blue Cross of California.
Seidman said he wanted to monitor how the drug is used before WellPoint decides on its reimbursement. WellPoint, an industry pacesetter, would be guided by the FDA-approved package insert, he said, a sign that the company won’t cover off-label use for allergies.
Xolair controls asthma by interrupting a biological chain reaction that can result in serious breathing difficulties. It differs from conventional medications such as steroids and antihistamines, which manage weepy eyes or other symptoms.
Xolair binds a protein called IgE and prevents it from triggering the release of histamines and other substances responsible for allergic reactions that can constrict breathing.
Genentech said it was preparing an analysis to show that Xolair is cost-effective for patients because it reduces the need for expensive emergency-room treatments. Genentech has been busy reassuring insurers that Xolair is not another Claritin, a costly allergy pill that WellPoint successfully fought to have sold without a prescription.
Some FDA committee members urged the agency to avoid language on the package insert that managed-care companies could use to limit patient access to Xolair. The panel said patients shouldn’t be required to try the full range of existing therapies before using Xolair.
“The package insert is critical to how it will be used, and managed-care companies will look at the minutiae,” said panelist Robert J. Fink, chairman of the pulmonary medicine department at Children’s National Medical Center in Washington.
The FDA panel expressed some concern about the long-term effects of Xolair, which aren’t known.
The panel recommended that patients have a positive allergy test before using Xolair and said it should not be used in patients older than 65. Genentech did not study enough seniors, whose immune systems are fragile, the panel said.
Work on the drug dates to the ‘90s, and Xolair has had a bumpy history. Genentech first sought permission to market Xolair for asthma and hay fever in June 2000, but the FDA told it to conduct more safety studies.
Meanwhile, Genentech became entangled in a dispute with Tanox Inc., a small Houston firm. Tanox sued Genentech, alleging that Genentech stole its idea, and Genentech countersued Tanox, claiming that its rival swiped its technology.
The legal settlement called for Genentech and Novartis, Tanox’s partner, to develop Xolair. Tanox now stands to receive a 10% royalty on sales.
Trading in Tanox’s shares were halted Thursday on Nasdaq because of the FDA news. Novartis’ shares closed at $40.24, up 9 cents, on the New York Stock Exchange.
