An FDA panel voted 6-5 against recommending approval of blood-pressure treatment Avapro as a kidney treatment for diabetics.
The approval was sought by
as marketing partner for the drug's manufacturer, Sanofi.
The panel said a follow-up period in the submitted study wasn't long enough, and that the studies themselves weren't significant enough to recommend approval. The FDA generally follows its committee's recommendations.
In a Bristol-Myers trial, patients with advanced kidney disease taking Avapro saw their risk of progression cut by 20% when compared with a placebo. In a second study, Avapro reduced the risk of kidney damage by 70% when compared with a placebo in patients just starting to show signs of renal impairment.