Forest Laboratories, Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration (FDA) did not approve the additional indication for Bystolic® (nebivolol) tablets as a treatment for stable chronic heart failure (CHF) as requested in the company’s Supplemental New Drug Application (sNDA). Bystolic is currently approved in the US for the treatment of hypertension.
However, FDA added information to the Specific Populations section of the product label under “Heart Failure” stating that in a placebo-controlled trial of 2,128 patients (1,067 with Bystolic, 1,061 placebo) over 70 years of age with chronic heart failure, on which the CHF submission was based, no worsening of heart failure was reported with nebivolol compared to placebo. If heart failure worsens physicians should consider discontinuation of Bystolic.
Forest Laboratories will continue to work closely with the FDA to discuss next steps.