Big happenings in FDA Advisory Panel land today: The pediatrics committee is looking at GlaxoSmithKline's asthma drugs Serevent and Advair, while another panel preps for a closer look at Abbott's proposed drug-coated stent, Xience.
You'll recall that the agency is worried about the possibility that asthma drugs may cause more trouble than they're worth. Reports of asthma-related death in patients using the drugs have been trickling in, and FDA is worried that they aren't as useful in children as they are in adults. More studies may be needed, the agency says.
Meanwhile, the FDA wants its stent panel to decide whether patients in ongoing trials of the Abbott product should be followed for a longer period of time before the agency considers approving it. Most of the data Abbott has submitted for review involves patient status after one year; the company also submitted information on 422 patients who've had the Xience stent for two years. The agency says the data looks good so far, but may be insufficient, because one of the big safety concerns for drug-eluting stents is clot formation after one year. Analysts say there's at least a 50 percent chance that the committee won't give its thumbs up to the stent yet.
- read the asthma article in Forbes
- read the WSJ article about the stent issues
ALSO: Regulators in Europe and the U.S. have joined together to create a common application form for developers seeking orphan drug status. Report