FDA panel votes down two asthma meds

When it came to the vote, the FDA's asthma drugs advisory panel wasn't as evenly split as it seemed. The experts voted unanimously to ban GlaxoSmithKline's Serevent and Schering-Plough/Novartis' Foradil from use in asthmatic kids. For adult use, the panel weighed in against Serevent 17 to 10 and against Foradil 18 to 9.

The group also unanimously approved the continued use in adults of GlaxoSmithKline's Advair and AstraZeneca's Symbicort. For adolescents, the vote split 23 to 3 in favor of Advair and 20 to 5 in favor of Symbicort. Advair got the nod for continued use in children in a more evenly divided vote, 13 to 11. Symbicort isn't approved for use in children.

So what's the difference among these drugs? They're all long-lasting beta agonists, right? Well, sort of. For starters, Serevent and Foradil are purely LABAs; Advair and Symbicort combine a LABA med and a steroid in a single inhaler. The biggest risks associated with LABAs come when the drugs aren't teamed up with a steroid, and the advisory panel concluded that too many doctors use Serevent and Foradil inappropriately (without a steroid). According to FDA data, about half of patients taking the two meds haven't been prescribed a steroid, and those who do have a steroid scrip often fail to take it.

GSK, Novartis and Schering-Plough are understandably miffed about the panel's decisions. They argued at the meeting that docs want to be able to choose which steroids to combine with which LABAs. But obviously that rationale didn't carry enough weight with the committee. GSK says it's hoping the FDA will decided that its proposed new labeling for Serevent--coupled with a risk management plan--will keep the drug in the asthma arsenal.

- read GSK's release [1]
- check out Novartis and Schering's statement [2]
- get the news [3] from the New York Times

Related Articles:
Panel to vote on asthma drugs' fate [4]
Asthma meds draw FDA scrutiny [5]
FDA asks for data on asthma meds [6]
Incontinence meds may impair thinking [7]