FDA rebuffs Forests hypertension drug for chronic HF
The FDA has snubbed Forest Laboratories' Supplemental New Drug Application submission that would have indicated nebivolol (Bystolic), currently approved for the treatment of hypertension, as an additional treatment for chronic heart failure (HF).
While the FDA did not approve of the drug’s use to treat HF, the agency did add information to the specific populations section of the drug's product label that included results of a previous placebo-controlled trial.
According to Forest, in a clinical trial of 2,128 patients (1,067 treated with Bystolic, 1,061 with placebo) who were all over 70 years old and diagnosed with chronic HF, “no worsening of heart failure was reported with nebivolol compared to placebo.”
The FDA also warned that if HF worsens in patients, that they should discontinue use of the drug.
Nebivolol was approved by the FDA in 2007 for its use to treat hypertension. In January the FDA's Cardiovascular and Renal Drug Advisory Committee unanimously vetoed nebivolol as a treatment for chronic heart failure.
While the FDA did not approve of the drug’s use to treat HF, the agency did add information to the specific populations section of the drug's product label that included results of a previous placebo-controlled trial.
According to Forest, in a clinical trial of 2,128 patients (1,067 treated with Bystolic, 1,061 with placebo) who were all over 70 years old and diagnosed with chronic HF, “no worsening of heart failure was reported with nebivolol compared to placebo.”
The FDA also warned that if HF worsens in patients, that they should discontinue use of the drug.
Nebivolol was approved by the FDA in 2007 for its use to treat hypertension. In January the FDA's Cardiovascular and Renal Drug Advisory Committee unanimously vetoed nebivolol as a treatment for chronic heart failure.