AZ's Asthma drug cleared by FDA panel

The benefits of AstraZeneca's asthma medication Symbicort outweigh its risks, a federal advisory panel said Thursday, removing a looming threat to the marketability of one of the company's top brands.

Symbicort and its closest competitor, Advair, avoided the fate of two other long-acting asthma drugs. The advisory panel to the Food and Drug Administration said Serevent and Foradil are too risky and should no longer be used for asthma.

The FDA has been reviewing the safety of long-acting beta agonists, or LABAs, which relax the muscles around airways to help asthmatic patients breathe more easily. Symbicort and Advair combine a LABA with an inhaled steroid to reduce inflammation, while Serevent and Foradil are LABA-only medications.

The FDA's own drug safety experts had recommended restrictions on all four drugs, including that none of them be used to treat asthmatic children. But the agency's respiratory specialists said the risks were manageable and no curbs were needed.

With its own experts deadlocked, the FDA called in an unusually large panel of 27 outside advisers. The medical and scientific experts said Advair and Symbicort should continue to be used with all patients.

The panel voted 26-0 with one abstention for Symbicort's use in adults, and 20-5 with two abstentions for asthma patients ages 12 to 17. AstraZeneca also has filed an application with the FDA to market Symbicort for asthma in patients 6 years and older.

The FDA usually follows the recommendations of its outside experts, although it is not required to do so.

Advair, made by GlaxoSmithKline, was the fourth-best selling drug in the world last year, with sales of $7.1 billion. Symbicort, a newer product introduced in the U.S. in 2006, brought in $1.57 billion in sales last year for AstraZeneca, whose U.S. headquarters is in Fairfax.

In preparation for the advisory panel meeting, the FDA analyzed findings from 110 clinical trials involving nearly 61,000 patients, comparing patients who took a medication containing a LABA with those who used a steroid alone to control their asthma. The agency found that each of the drugs except Advair carried an increased risk of hospitalization or death.

But AstraZeneca last week said the FDA examined only a small portion of the information it sent at the agency's request. The drug maker said its analysis of clinical trials involving more than 23,000 patients found no evidence of an increased risk of asthma-related deaths or hospitalizations for patients taking Symbicort.