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Forest Should Conduct More Bystolic Studies For CHF Approval, Panel Says

Executive Summary

An FDA panel decided that the agency should not approve Forest Laboratories' Bystolic (nebivolol) for chronic heart failure based on the current evidence, but suggested the drug could be approved for this added indication if the drug maker conducts a non-inferiority trial against other beta-blockers

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FDA acts on heart failure application for Forest's Bystolic

The agency did not approve the full additional indication for treatment of stable chronic heart failure as requested in Forest's nebivolol sNDA, the firm announced Feb. 23, but the firm did get some of the trial data included in labeling. VP-Investor Relations Frank Murdolo explained in an email exchange that FDA did issue a supplement approval, but narrowed the approval to inclusion of additional safety information based on the CHF study. Labeling now includes a heart failure section under "special populations" that reports that in a placebo-controlled trial of 2,128 patients over 70 years of age with CHF, no worsening of heart failure was seen with nebivolol compared to placebo. Since hypertension (for which Bystolic is approved) may lead to heart failure, it is important to note that if a patient is treated for hypertension with Bystolic and develops heart failure, Bystolic does not make the condition worse, Murdolo said. Forest continues to work with FDA on a plan to move forward in CHF; the advisory committee recommended a non-inferiority study against other beta blockers (1"The Pink Sheet," Jan. 18, 2010)

FDA acts on heart failure application for Forest's Bystolic

The agency did not approve the full additional indication for treatment of stable chronic heart failure as requested in Forest's nebivolol sNDA, the firm announced Feb. 23, but the firm did get some of the trial data included in labeling. VP-Investor Relations Frank Murdolo explained in an email exchange that FDA did issue a supplement approval, but narrowed the approval to inclusion of additional safety information based on the CHF study. Labeling now includes a heart failure section under "special populations" that reports that in a placebo-controlled trial of 2,128 patients over 70 years of age with CHF, no worsening of heart failure was seen with nebivolol compared to placebo. Since hypertension (for which Bystolic is approved) may lead to heart failure, it is important to note that if a patient is treated for hypertension with Bystolic and develops heart failure, Bystolic does not make the condition worse, Murdolo said. Forest continues to work with FDA on a plan to move forward in CHF; the advisory committee recommended a non-inferiority study against other beta blockers (1"The Pink Sheet," Jan. 18, 2010)

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