(Updated with comments from the FDA in the fifth paragraph and adds additional details.)
By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration advisory panel Thursday split on the benefits and risks of a class of asthma drugs, but backed the use of combination products Advair and Symbicort for certain asthma patients.
Advair, by GlaxoSmithKline PLC (GSK), and Symbicort, by AstraZeneca (AZN), fall into a class of drugs known as long-acting beta-agonists, or LABAs. The drugs are used by about six million patients with moderate-to-severe asthma whose symptoms aren't well-controlled by other drugs including inhaled corticosteroids, which are the backbone of asthma treatment, and are designed to reduce airway inflammation. Advair is Glaxo's top-selling drug and the dominant drug in its class with $2.9 billion in U.S. sales through the first nine months of the year.
Advair and Symbicort both contain a long-acting ingredient along with an inhaled corticosteroid. Two other drugs, Serevent, from Glaxo, and Foradil, made by Novartis AG (NVS) and marketed in the U.S. by Schering-Plough Corp. (SGP), don't contain an inhaled corticosteroid. Current treatment guidelines recommend the use of those drugs with an inhaled corticosteroid but studies suggest many patients don't consistently use both products.
The panel essentially backed the use of Advair and Symbicort for both adults and children but said the benefits of Foradil and Serevent didn't outweigh the risks of the drugs as currently approved. Several panel members said the labels for Foradil and Serevent should be rewritten to make it clear to patients and doctors that the products should be used in addition to inhaled corticosteroid and not alone. Novartis and GlaxoSmithKline said they would support such a labeling change but would be opposed to an FDA decision to stop the companies from marketing the drugs as asthma treatments.
John Jenkins, director of the FDA's Office of New Drugs, said Foradil's and Serevent's labels could be strengthened to discuss proper use of the drugs and said the products could also be subject to a formal agency risk-mitigation program. He said asthma patients shouldn't stop taking any of their medications without talking to their doctors.
If the FDA were to take the more drastic step of pulling the asthma indication for Foradil and Serevent, the drugs would remain on the market for chronic obstructive pulmonary disease.
Long-acting drugs have been the subject of an on-going FDA safety review for several years and the drugs' labels already warn they could "increase the risk of asthma-related death." The drugs are designed to prevent the tightening of muscles around the airway. About 22 million Americans, including about 6.5 million children, have asthma, a chronic condition marked by narrowing of the airways.
The FDA called a panel of outside medical experts to discuss the drugs during a two-day meeting and to resolve agency differences about whether the drugs should continue to be marketed as asthma treatments in children and adults due to lingering concerns that the products increase the risk of asthma-related side effects.
The FDA's drug-safety division is recommending that the drugs not be marketed for children, and in some cases adults, while the agency's pulmonary division stated that removing the products from the market would be "extreme."
"We don't have a lot of disagreement in the FDA that the risk is real," FDA's Jenkins said. "Does the risk mean these drugs are unacceptable for marketing?"
Both the FDA and the companies presented data to the panel on Wednesday. The FDA's analysis of the four drugs said that, as a group, the products are linked with an increased risk of asthma-related side effects, with higher risks seen in children. The analysis looked at whether the drugs increased a combined measure of asthma-related death, hospitalization and asthma-related intubations (the placement of a tube in patients' noses or mouths to help them breathe). Overall, it found an additional 2.8 asthma-events per 1,000 patients treated with a LABA compared to patients not receiving the drugs with higher risks seen in children ages 4 to 11.
When looking at specific drugs, the FDA said the risk was seen with Foradil, Serevent and Symbicort "but was not apparent in Advair." The agency also said the increased risk was far less when using inhaled corticosteroids, which current asthma-treatment guidelines recommend.
The American College and the American Academy of Allergy, Asthma and Immunology along with the American Academy of Pediatrics said all four of the drugs should remain available as asthma treatments. The drugs are used to treat patients with moderate-to-severe asthma.
The FDA said the increased asthma-event rate was largely driven by an increase in hospitalizations. There were 20 asthma-related deaths in the studies; of those, 16 were patients on Serevent and four were patients in the non-LABA group. The analysis involved 110 trials and 60,954 patients. The bulk of the patients were from Serevent trials, with about 43,000 patients, the agency said.
The data were submitted by the four drug manufacturers. Both Serevent and Advair are approved for use in children and adults ages 4 and older while Foradil is approved for use in children and adults age 5 and older, and Symbicort is approved for use in people age 12 and older in the U.S.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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Publié le 11 Décembre 2008 Copyright © 2008 Dowjones