FDA Panel Rejects Wider Use for Hypertension Drug Bystolic

The hypertenstion drug Bystolic should not be granted broader approvals for treating some heart failure patients, a Food and Drug Administration advisory panel has ruled.

Drug maker Forest Laboratories Inc. has asked the FDA to approve Bystolic, which was launched in 2008 to treat high blood pressure. The company wants permission to market the drug to reduce deaths and heart-related hospitalizations in heart failure patients, according to a Reuters news report.

But in an 8-0 vote, advisory panel members who advise the FDA on new drug approvals said they will not recommend approval of Bystolic. While the FDA is not required to follow the recommendations of its advisory panels, it most often does. A final ruling from the FDA is expected by March 1.

Questions Raised About Clinical Study

Bystolic got a big thumbs-down from the advisory panel in part because members said effectiveness data from the clinical trial Forest submitted to back the proposed wider use were not strong enough to win their endorsement, even when they considered other studies showing similar drugs helped heart failure patients, according to Reuters.

“I would like to see some additional corroborating evidence,” said panelist Dr. Scott Emerson, a statistician at the University of Washington.

Last week, an FDA had said changes to Forest’s heart failure study raised questions about the findings. That warning apparently hit home with the advisory panel, which rejected the request based in part on questions about the clinical trial findings.

Chronic Heart Failure Patients Targeted

Chronic heart failure is a condition in which the heart cannot pump enough blood throughout the body, which can lead to tiredness, shortness of breath and other symptoms. The condition affects about five million people in the United States and contributes to about 300,000 deaths each year, according to the National Institutes of Health.

Bystolic is known generically as nebivolol and belongs to the family of heart drugs known as beta blockers, which reduce heart rate and lower blood pressure. Two beta blockers are currently approved for heart failure, GlaxoSmithKline Plc’s Coreg and AstraZeneca Plc’s Toprol, along with less-expensive generic copies of both drugs.

No related posts.