Actavis High Blood Pressure Drug Fails to Win U.S. ApprovalAnna Edney
Actavis Plc failed to win U.S. approval to sell its treatment for high blood pressure that combines two heart drugs already on the market.
The Food and Drug Administration rejected the combination pill made up the active ingredients in Actavis’s Bystolic and Novartis AG’s second-best seller Diovan, Actavis said today in a statement. A panel of advisers to the FDA voted 6 to 4 in September against recommending the treatment for approval.
FDA staff members had questioned whether the medicine, a combination of nebivolol and valsartan, would be a better treatment than the highest dose of one of the drugs alone. About 67 million American adults, or 1 in 3, have high blood pressure, which increases the risk of heart attack and stroke, according to the Centers for Disease Control and Prevention.
Actavis, which is based in Dublin with operations in Parsippany, New Jersey, is reviewing the FDA’s rejection letter and will “determine the appropriate next steps,” David Nicholson, senior vice president of the company’s global brands research and development, said in the statement.
Actavis acquired the experimental medicine when it purchased Forest Laboratories Inc. in July for $20.8 billion. Forest submitted the application for the drug to the FDA before the sale. Actavis last month agreed to acquire Allergan Inc., the maker of the anti-wrinkle treatment Botox, for about $66 billion in the year’s biggest pharmaceutical deal as it seeks to become one of the largest global drugmakers.