FDA Denies Approval for Actavis' Hypertension Combo Treatment

December 29, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Generic drug maker Actavis Plc appears to have recovered slightly from its bad news that week that U.S. health regulators had denied approval a fixed-dose combination of nebivolol and valsartan, its latest attempt to tackle the lucrative hypertension market.

Shares of Actavis were up almost 2 percent after earlier dipping on the news that the U.S. Food and Drug Administration has nixed its hypertension drug Bystolic Dec. 23, despite trial data for a single Phase III randomized, controlled trial of approximately 4,100 patients.

The FDA typically issues a complete response letter when it decided that a new or generic treatment cannot be approved in its current form.

"Although we are disappointed in the receipt of a complete response letter, Actavis remains committed to bringing treatments to market that address the significant public health issue of cardiovascular disease," said David Nicholson, senior vice president for Actavis Global Brands Research and Development.

"Bystolic is a safe and effective option that is commonly used in combination with other antihypertensive medications to help patients reach blood pressure treatment goals. We will review the complete response and determine the appropriate next steps," he said.

Nonetheless, Actavis declined to provide the FDA’s complete response letter and though it did say it would take “appropriate next steps” to bring the drug back up for review as soon as possible.

The study Actavis submitted to the FDA did find that the drug combination was more effective in reducing blood pressure in patients of hypertension, compared with independent doses of nebivolol and valsartan. But the FDA found some of the data lacking in some way, prompting last week’s decision and the company’s bumpy stock movements over the last two trading days.

According to the National Institute for Health Statistics, approximately 30 percent of adults in the United States have hypertension and the Centers for Disease Control have dubbed it the "silent killer" because it often has no warning signs or symptoms and has been associated with serious cardiovascular (CV) risks, such as stroke and myocardial infarction.