FDA panel rejects expansion of Forest drug

Advisors to the US Food and Drug Administration have unanimously rejected Forest Laboratories attempt to market its antihypertensive Bystolic for the treatment of chronic heart failure.

The agency’s Cardiovascular and Renal Drugs Advisory Committee has voted 8-0 against recommending approval of Bystolic (nebivolol) for reducing deaths and heart-related hospitalisations in heart failure patients. The decision is not a surprise, given that papers from FDA staff reviews had stated that data from a clinical trial Forest submitted to back an extended label were not strong enough.

Forest had submitted a study involved 2,135 patients with an average age of 76 who were treated for 19 months. However the panellists claim that the results did not show a significant difference in the reduction of death and heart-related hospitalisations for patients treated with Bystolic, a beta blocker, compared with placebo.

The FDA reviewers also expressed concerns about the interpretability of study data, as Forest made major adjustments to the design of the trial over the four years of its duration. Also the trial was conducted in Europe and questions were asked as to how applicable it was to US medical practice.

Forest launched Bystolic in 2008 for high blood pressure and sales for the fiscal second quarter ended September 30 last year reached $40.7 million. The FDA will make its final decision on the new indication by March 1.