Bystolic, Shot Down by FDA for Heart Failure Indication

Silver Spring, MD (updated January 13, 2010) - An FDA advisory panel voted unanimously not to recommend approval of nebivolol (Bystolic, Forest Laboratories) for the treatment of chronic heart failure. The FDA had already announced it was leaning away from expanding the drug's indication from hypertension, for which it has been available for several years, to include heart failure, for which there are currently only two approved beta blockers in the US.

The main reason both the panel and the FDA opposed the approval: a weak showing in the only trial submitted in its support, the Study of Effects of Nebivolol Intervention on Outcomes and Rehospitalization in Seniors with Heart Failure (SENIORS).

The drug is already available for heart failure in 71 countries, its advocates said at the hearing.

The 8-0 vote from the Cardiovascular and Renal Drugs Advisory Committee followed a day in which panelists had shown a willingness to overlook certain protocol changes made during the trial that had concerned the FDA.

But there was at least one door left open: most of the panel agreed that there's room for additional nebivolol trials in heart failure, although probably a noninferiority comparison with other beta blockers, not a placebo-controlled trial. "I think most of us agreed in the end that if [the sponsor] wants to pursue this indication," Dr Darren McGuire, an FDA advisory panelist said, "SENIORS could count as one of the two positive trials required."