US Panel Disapproves Wider Use of Nebivolol Drug

US Panel Disapproves Wider Use of Nebivolol Drug

A US cardiovascular advisory panel on Monday unanimously disapproved Forest Laboratories Inc's bid to promote a hypertension pill nebivolol (Bystolic) for treatment of heart failure.

The 8-0 vote emerged as no surprise. The panelists claimed that there was no convincing evidence to back the expanding indications for the beta blocker. The drug had gained approval as a hypertension treatment medicine in 2007.

The FDA usually follows panel recommendations when deciding whether to approve drug applications. A decision is due by March 1.

Forest is in a process to extrapolate the use of existing drugs and introduce new products to the market ahead of the expected patent expiration in early 2012 of its biggest product, antidepressant Lexapro.

Bystolic was launched in 2008 for treating high blood pressure. The drug is expected to fetch a $40.7 million sale in 2010.

The company tested its drug in more than 2,000 heart failure patients aged 70 and older to observe if the drug reduced deaths or heart-related hospitalizations compared with a placebo. Forest claimed Bystolic cut the risk from 35 percent with a placebo to 31 percent with the drug.

Forest shares registered a gain of nearly 1.2%, closing at $31.40 on the New York Stock Exchange.