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Sept. 9 (Bloomberg) -- Actavis Plc failed to win the backing of U.S. regulatory advisers for an experimental pill that combines two existing drugs to lower high blood pressure.
The combination pill shouldn’t be approved to treat hypertension because it doesn’t provide a clinically meaningful benefit over the two drugs alone, Food and Drug Administration advisers said today at a meeting. The advisory panel voted 6 to 4 against recommending the treatment.
Regulators have questioned whether Dublin-based Actavis’s combination of nebivolol and valsartan would be a better treatment than the highest dose of one of the medicines alone. Using the combination treatment means it would take longer for patients to get their blood pressure under control, the FDA’s Division of Cardio-Renal Drug Products said in a report.
“Approving a drug with a very small effect like this will lead to choosing this agent over other combinations or other individual agents that work better,” said James DeLemos, a panelist and cardiology service chief at Parkland Memorial Hospital in Dallas. “So I think that we don’t need 47 combinations of blood pressure medicines.”
The FDA, which doesn’t have to follow the advice of the advisory committee, is scheduled to decide whether to approve the drug by Dec. 24, according to a report by Bloomberg Intelligence.
About 67 million Americans have high blood pressure. The condition is linked to heart attacks, strokes and heart failure, and contributed to 348,000 deaths in the U.S. in 2009, according to the Centers for Disease Control and Prevention.
About two-thirds of people with high blood pressure need more than one drug to treat it, according to Forest Laboratories Inc., which Actavis bought in July for $20.8 billion. Forest submitted the application for the combination drug to the FDA before the sale.
The pill being reviewed combines the key ingredient in Actavis’s Bystolic, nebivolol, and valsartan, the active ingredient in Novartis AG’s second-best seller Diovan. Diovan lost patent protection two years ago, yet only faced generic competition in June when Ranbaxy Laboratories Ltd. had its version approved after earlier manufacturing problems.
Forest Laboratories said that tests showed the combination therapy led to greater reductions in blood pressure after eight weeks than the two pills alone, and could give high blood pressure patients who need two drugs an additional treatment option.
Diovan, which relaxes blood vessels, generated $3.52 billion in sales last year for Basel, Switzerland-based Novartis. Forest Laboratories last year sold $455 million of Bystolic, which blocks a chemical that causes blood vessels to narrow.
To contact the reporters on this story: Kelly Gilblom in New York at firstname.lastname@example.org; Anna Edney in Washington at email@example.com To contact the editors responsible for this story: Reg Gale at firstname.lastname@example.org Drew Armstrong, Andrew Pollack