Tekturna HCTTreatment for Hypertension
Update: Tekturna HCT Now FDA Approved - January 18, 2008
Single-Tablet Combination of Tekturna and Diuretic, an Important New Option for People With High Blood Pressure, Accepted for Review in U.S.
Tekturna, approved in the U.S. in March 2007, represents the first new type of medicine for treating high blood pressure in more than a decade
EAST HANOVER, N.J., May 21, 2007 /PRNewswire/ -- A single-tablet combination of two high blood pressure medicines - the recently approved direct renin inhibitor Tekturna (aliskiren) and the widely used diuretic hydrochlorothiazide - has been accepted for U.S. regulatory review by the Food and Drug Administration.
Tekturna HCT(1) represents the first regulatory submission for a single-tablet combination therapy involving Tekturna, which is the first new type of high blood pressure medicine in more than a decade. Tekturna was approved by the U.S. Food and Drug Administration in March 2007, while a decision on European Union approval is expected by the end of 2007.
Single-tablet combination therapies like Tekturna HCT may make blood pressure management more convenient for people by reducing the number of pills they take daily. High blood pressure affects nearly one in three adults in the U.S., and an estimated 70% of these patients are not currently at their target blood pressure level based on established guidelines. Most patients require two or more medicines to reach their goal.
"Several studies show that many adults with high blood pressure remain uncontrolled despite treatment, because too often physicians fail to treat aggressively enough," said Alan Gradman, MD, Chief of the Division of Cardiovascular Diseases at the Western Pennsylvania Hospital in Pittsburgh, PA. "A tablet combining the first direct renin inhibitor and a diuretic would give doctors an important new treatment option to help patients reach their treatment goals."
New clinical data involving 1,625 patients, presented today at the American Society of Hypertension, Inc. (ASH) Annual Scientific Meeting and Exposition (ASH 2007) meeting in Chicago, showed that Tekturna produced significant blood pressure lowering effects over a one-year period, both alone and in combination with hydrochlorothiazide. Tekturna plus HCT was generally well tolerated, with the most common side effects in this study being bronchitis (6.1%), nasopharyngitis (5.1%) and headache (3.5%).
Hydrochlorothiazide is a diuretic, commonly known as a "water pill," that helps the body get rid of unneeded water and salt in the urine. It was among the first high blood pressure treatments, as removing fluid helps control blood pressure.
The submission of Tekturna HCT was based on data from seven clinical trials involving more than 6,200 patients, including the data presented at the ASH meeting. Submissions were made for four different dosage combinations of Tekturna and hydrochlorothiazide: 150/12.5 mg tablets, 150/25 mg tablets, 300/12.5 mg tablets and 300/25 mg tablets.
Tekturna, developed in collaboration with Speedel, is the first approved direct renin inhibitor and received U.S. approval based on results of an extensive clinical trial program showing significant blood pressure reductions for a full 24 hours.
"Tekturna HCT represents an initial success in our efforts to explore the benefits of combining this innovative medicine with other complementary high blood pressure agents. We will continue to assess other combinations that would be of use for patients and physicians," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
Women taking Tekturna who become pregnant should stop taking Tekturna and call their physician right away. Tekturna may harm an unborn baby, causing injury and even death. Women who plan on becoming pregnant and are taking Tekturna should speak with their physician about other treatment options.
Angioedema has been reported in patients taking Tekturna.
The most common side effect experienced by more patients taking Tekturna than patients taking a sugar pill (placebo) was diarrhea. Other less common reactions to Tekturna include cough and rash.
As a direct renin inhibitor, Tekturna acts by targeting renin - an enzyme responsible for triggering a process that can contribute to high blood pressure. Tekturna is now available by prescription in 150 mg or 300 mg tablets as a once-daily oral therapy.
Tekturna was developed in collaboration with Speedel.
For more information about Tekturna call 1-888-TEKTURNA (1-888-835-8876) or visit www.tekturna.com.
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as "is expected", "may make", "would give", "will continue", or similar expressions, or by express or implied discussions regarding potential future regulatory filings, approvals or future sales of Tekturna HCT or Tekturna. Such statements reflect the current views of the Novartis group of companies with respect to future events and are subject to certain risks, uncertainties and assumptions. There can be no guarantee that Tekturna HCT will be approved for sale in the United States or any other market or that Tekturna will be approved for sale in any market where it has not already been approved, or that Tekturna HCT or Tekturna will reach any particular sales levels. In particular, management's expectations regarding the approval and commercialization of Tekturna HCT or Tekturna could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data and new clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 101,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
(1) The trade name Tekturna HCT is currently pending regulatory, including FDA, approval Heather Rose 917-859-4086 onsite at ASH in Chicago 862-778-1414 (office)email@example.com
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Posted: May 2007
- FDA Approves Tekturna HCT as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent - July 21, 2009
- Tekturna HCT, a Single-Tablet Combination of Tekturna and a Diuretic, Receives US Approval for Treatment of High Blood Pressure - January 22, 2008