Editor's note: This is an updated version of a previously published story.
Swiss pharmaceutical giant Novartis (NVS) scored a major coup over rivals with U.S. approval of the first new blood pressure medication in more than a decade. Set to hit the market later this month, Tekturna is the first in a new class of hypertension drugs known as direct renin inhibitors. Developed in partnership with Swiss biotech firm Speedel, the drug solves a puzzle that has vexed the industry for more than 30 years: how to block renin, a kidney enzyme that raises blood pressure, at its origin.
"Hypertension is rightly called 'the silent killer' because it usually has no symptoms until it causes major damage to the body organs," said Douglas Throckmorton, deputy director of the U.S. Food & Drug Administration's Center for Drug Evaluation & Research, in a Mar. 6 statement. "Today's approval adds a new, safe, and effective treatment option for people who need help to control their blood pressure."
In recent years, a number of rival drug companies have accelerated their efforts to develop this promising new class of hypertension drugs. Four years ago, Merck (MRK) inked a $272 million deal with Swiss biotech Actelion to develop renin inhibitors, while Britain's GlaxoSmithKline (GSK) formed a similar partnership in 2005. Dresdner Kleinwort analysts estimate that with the Mar. 6 U.S. FDA approval of Tekturna, Novartis has a five-year head start over rivals.
For Novartis, it's just the latest offering in a growing franchise of hypertension drugs. In addition to the company's best-selling drug, Diovan, a hypertension drug with more than $4 billion in 2006 sales, Novartis gained FDA approval for Exforge, a combination of two existing drugs, Diovan and the calcium channel blocker amlodipine besylate.
The market for hypertension is massive. One in four American adults suffers from hypertension, putting them at increased risk of cardiovascular disease, which is currently the world's No. 1 killer. The U.S. hypertension market is currently worth $18 billion.
But despite more than 100 different hypertension drugs on the market, an estimated 70% of Americans with high blood pressure are unable to control it. "Many patients use two or three different drugs and still struggle to get their blood pressure down," says Dr. Marc Pfeffer, a professor of medicine at Harvard Medical School and cardiologist at Brigham & Women's Hospital. "Doctors need more in their armamentarium, and Tekturna offers an exciting, novel therapeutic option for treating hypertension."
Blocked at the Beginning
Analysts say Tekturna offers some potential advantages over existing treatments. The most important is sustained blood pressure control over 24 hours, with fewer side effects than with existing treatments. That's why many analysts are predicting it will soon become a blockbuster. Dresdner Kleinwort estimates Tekturna will generate $350 million in sales this year, before reaching more than $2 billion in revenues in 2011.
The big hope, however, is that in hypertension patients Tekturna may ultimately reduce cardiovascular complications and the progression of kidney failure. Unlike existing high blood pressure drugs such as ACE inhibitors, Tekturna works by suppressing renin at the very beginning of the process, lowering plasma renin activity.
This approach is one of the most effective ways of reducing the progression of kidney disease. Novartis plans to conduct a study of 8,000 patients with existing cardiovascular ailments to see if Tekturna can also help, over time, to reduce cardiovascular events and the progression of renal disease.
Novartis is also conducting additional long-term outcome studies which, if successful, could vastly increase market share. There are studies planned to determine whether Tekturna delays the time to diabetic complications and another to determine the drug's usefulness in the treatment of heart failure. It will be several years before the results of such studies are known, however.
In the meantime, Novartis hopes to market the drug as both a standalone therapy and for use in combination with other medications. Convincing doctors and patients to switch to a newer and costlier drug (Novartis has not revealed Tekturna's price) won't be easy. Still, the company is counting on patients like Earl Stough to give it a go.
Ever since he was diagnosed with high blood pressure eight years ago, the 59-year-old network analyst at Avera McKennan Hospital and University Health Center in Sioux Falls, S.D., has fought a losing battle to control it. Stough tried, unsuccessfully, almost every hypertension drug on the market, often in combination before enrolling in clinical trial for Tekturna last spring. "I noticed a major difference," he says. "For the first time ever, my blood pressure was under control."