Healthcare Industry News: amlodipine besylate
News Release - April 27, 2006
US Submission of Exforge(R) Accepted for Review by the FDA as a New Therapy Option for High Blood PressureExforge a single-tablet combination of the leading antihypertensive medicines amlodipine (CCB) and valsartan (ARB)
Regulatory submission includes results from more than 5,000 hypertensive patients
EAST HANOVER, N.J., April 27 (HSMN NewsFeed) -- Novartis announced today that the new drug application (NDA) for Exforge® (amlodipine besylate/valsartan) was accepted for standard review by the US Food and Drug Administration (FDA) as a new treatment option for people with high blood pressure. The submission for EU approval was completed earlier in 2006.
In clinical trials, Exforge demonstrated clinically significant blood pressure reductions. Exforge utilizes two complementary mechanisms of action through the calcium channel blocker (CCB) amlodipine and the angiotensin receptor blocker (ARB) valsartan. Both agents are the No. 1 prescribed branded medications in their respective classes.
More than 65 million Americans, or one in three adults, are estimated to have high blood pressure, with approximately 70% of them not under control. Among people who are treated for hypertension, approximately 50% are still estimated not to have achieved their treatment blood pressure goal.
"With so many patients still uncontrolled, a real need exists for an agent that can help people reach and maintain their blood pressure goal," said Dr. James Shannon, Head of Development, Novartis Pharma AG. "Exforge has the added benefit of bringing together the efficacy of two proven mechanisms of action, resulting in significantly lower blood pressure."
The US filing was based on a robust clinical trial program involving more than 5,000 hypertensive patients. The program included five controlled trials in which more than 2,600 patients received Exforge once daily. A single daily dose of Exforge provided clinically significant blood pressure reductions and was well tolerated.
Adverse events were generally mild and transient in nature. The most common side effects in clinical trials were peripheral edema, nasopharyngitis, upper respiratory tract infections and dizziness. The incidence of peripheral edema was statistically lower in people treated with Exforge than in people treated with amlodipine monotherapy. All drugs that act directly on the renin angiotensin system carry a warning that they should not be used in pregnant women due to risk of injury and even death to the unborn child.
High blood pressure is usually a lifelong condition that, while incurable, can be controlled with proper treatment. If left untreated, high blood pressure can have serious health consequences, including heart attack and stroke.
This release contains certain forward-looking statements, relating to the Group's business, which can be identified by the use of forward-looking terminology such as "new therapy option," "can help," "added benefit," or similar expressions, or by express or implied discussions regarding potential marketing approvals or future sales of Exforge. Such statements reflect the current views of the Group with respect to future events and are subject to certain risks, uncertainties and assumptions. There can be no guarantee that Exforge will be approved for any indications in any market, nor that it will reach any particular sales levels. In particular, management's expectations regarding commercialization of Exforge could be affected by, among other things, additional analysis of Exforge clinical data; new clinical data; unexpected clinical trial results; 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 the Company's current Form 20-F on file with the U.S. 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 (NYSE: NVS ) -- 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 and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
Source: Novartis Pharmaceuticals
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