Healthcare Industry News: amlodipine besylate
News Release - June 21, 2007
Exforge(R) Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood PressureExforge offers two of the most prescribed high blood pressure medicines in a convenient single-tablet form(1,2,3)
Powerful new treatment option for millions in the US with high blood pressure(4)
Up to nine out of 10 patients reach high blood pressure treatment goal while taking Exforge during clinical trials(5)
EAST HANOVER, N.J., June 21 (HSMN NewsFeed)-- Exforge®, a single- tablet combination of two of the most prescribed high blood pressure medicines, has been granted final US Food and Drug Administration approval and is expected to be available soon as an effective treatment option for millions in the US who suffer from high blood pressure(1,2,3).
Exforge is the first medicine of its kind to combine the active ingredients of an angiotensin receptor blocker -- Diovan® (valsartan) -- and a calcium channel blocker -- Norvasc®(*) (amlodipine) -- with the convenience of a single, once-daily tablet(1,2,3).
"High blood pressure continues to be a major public health issue in the US. Many patients will require multiple medications to achieve blood pressure control," said Bertram Pitt, MD, FACC, and a Professor of Medicine Emeritus at the University of Michigan School of Medicine Division of Cardiology. "This new treatment offers great efficacy and improved convenience with a single tablet that will simplify treatment for patients."
The US approval of Exforge was supported by an extensive clinical program involving more than 5,000 patients(1). The US Food and Drug Administration had tentatively approved Exforge in December 2006 and has now granted final approval.
Exforge was approved in January 2007 in the European Union and has already been made available in nine EU countries, including Germany and the UK, with further launches planned. Exforge is also available in Switzerland.
In two placebo-controlled trials, Exforge helped up to nine out of ten patients reach their treatment goal of diastolic blood pressure under 90 mmHg, or more than a 10 mmHg reduction in diastolic blood pressure from baseline levels(5). Diastolic blood pressure is measured in millimeters of mercury (mmHg) when the heart is at rest between beats.
In two further clinical trials, Exforge demonstrated superior blood pressure lowering efficacy in patients uncontrolled when taking either valsartan or amlodipine alone, the two high blood pressure drugs combined in Exforge(1).
"Exforge continues our strong heritage in treating high blood pressure, in this case bringing together two of the most widely-used medicines in a single pill," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Aggressively treating high blood pressure is key, so we are excited to be able to provide physicians and patients with this first-of-a-kind combination to help patients reach recommended blood pressure treatment goals."
Exforge combines the complementary actions of Diovan -- which inhibits angiotensin II, a hormone that causes blood vessels to tighten and narrow -- and amlodipine, which inhibits the entrance of calcium into the blood vessel walls. Both of these medicines allow blood vessels to relax so that blood can flow more easily(1,2,3).
High blood pressure causes damage to the arteries, burdening the heart, kidneys, brain and other vital organs(6). At present, high blood pressure affects at least 29% of all adults in the US and approximately one billion people suffer from the condition globally(7,8). The number of people globally with high blood pressure is expected to reach about 1.6 billion by 2025(9).
Exforge is not indicated for initial high blood pressure therapy. It has been approved for use in high blood pressure patients who have not been controlled through the use of any type of medicine in the angiotensin receptor blocker or calcium channel blocker classes, and for patients who have experienced dose-limiting side effects on either valsartan or amlodipine. These include amlodipine-induced edema (swelling), dizziness or flushing(1).
In the Exforge clinical trials, adverse events were generally mild and transient in nature. Side effects that occurred more frequently with Exforge than placebo in clinical trials were peripheral edema (fluid retention), nasopharyngitis, upper respiratory tract infections and dizziness(1).
Important Safety Information about Exforge
Taking EXFORGE during pregnancy can cause injury and even death to your unborn baby. If you get pregnant, stop taking EXFORGE and call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. See Warnings in complete Prescribing Information by going to www.exforge.com.
EXFORGE is contraindicated in patients who are hypersensitive to amlodipine or valsartan.
Excessive hypotension was seen in 0.4% of patients treated with EXFORGE. Volume and/or salt-depletion should be corrected in patients before administering EXFORGE or symptomatic hypotension may occur. Caution should be observed when initiating therapy in patients with heart failure or recent myocardial infarction and in patients undergoing surgery or dialysis.
Rarely, increased frequency, duration, and/or severity of angina or acute myocardial infarction have developed in patients treated with calcium channel blockers; particularly patients with severe obstructive coronary artery disease.
In patients with renal artery stenosis or severe renal impairment, care should be exercised with dosing of EXFORGE. In patients with severe HF, decline in renal function and rarely, acute renal failure and/or death has been associated with inhibiting the renin-angiotensin system.
In patients with congestive heart failure, dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required. Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function.
Amlodipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker.
The most common adverse events that occurred more frequently with EXFORGE than placebo were peripheral edema (5% vs. 3%), nasopharyngitis (4% vs. 2%), upper respiratory tract infection (3% vs. 2%) and dizziness (2% vs. 1%).
Please see full Prescribing Information available at www.exforge.com.
Exforge is not indicated for the initial treatment of hypertension.
Important Safety Information About Diovan
DIOVAN can harm an unborn baby and even cause death. If you get pregnant, stop taking DIOVAN. Call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. See Warnings in complete Prescribing Information by going to www.diovan.com.
DIOVAN is contraindicated in patients who are hypersensitive to any component of this product.
Volume and or salt depletion should be corrected in patients prior to administering DIOVAN or symptomatic hypotension may occur.
Care should be exercised with dosing of DIOVAN in patients with severe renal impairment. As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be observed in susceptible individuals (e.g. patients with renal artery stenosis or severe heart failure).
No significant differences between adverse events, DIOVAN and placebo. AEs more frequent with DIOVAN than placebo: viral infection (3% vs 2%), fatigue (2% vs 1%), abdominal pain (2% vs 1%); the most common AEs: headache and dizziness. An increase in dizziness was observed with the 320 mg (8%) vs 10 mg to 160 mg (2% to 4%).
DIOVAN is indicated for the treatment of hypertension.
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as, "powerful new treatment option", "expected", "will", "planned", "continues our strong heritage" or similar expressions, or by express or implied discussions regarding potential future revenue from Exforge. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Exforge will reach any particular sales levels. In particular, management's expectations regarding the approval and commercialization of Exforge in the US or in other markets could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected intellectual property issues involving the expiration of market exclusivity of amlodipine besylate; competition in general; increased government, industry, and general public pricing pressures; unexpected clinical trial results, including additional analysis of clinical data, or new clinical data; our ability to obtain or maintain patent or other proprietary intellectual property protection; 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 (NYSE: NVS ), a world leader in offering medicines to protect health, cure 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. 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. Novartis is the only company with leadership positions in these areas. 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 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
(1) Exforge (amlodipine besylate and valsartan) Prescribing Information Draft. December 2006.
(2) Diovan Web site. http://www.diovan.com/info/about/about_diovan.jsp. Accessed November 28, 2006.
(3) Norvasc Web site. http://www.norvasc.com/high-blood-pressure- medicine/about-norvasc.asp?print=true Accessed November 28, 2006.
(4) Rosamond W, Flegal K, Friday G, et al. for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2007 update. A report from the American Heart Association Statistics Committee and Stroke Subcommittee. Circulation. 2007:115.
(5) Philipp, T. Two multi-center, 8-week randomized, double blind, placebo controlled, parallel group studies evaluating the efficacy and tolerability of amlodipine and valsartan in combinations and as monotherapy in adult patients with mild-to-moderate hypertension. Clinical Therapeutics Journal, 2007; 29:563-580.
(6) American Heart Association. "High blood pressure." Available at: http://americanheart.org/presenter.jhtml?identifier=2114.
(7) Ong KL, Cheung BMY, Man YB, et al. Prevalence, awareness, treatment, and control of hypertension among United States adults 1999-2004. Hypertension. 2007;49:69-75.
(8) Chobanian AV, Bakris GL, Black HR, et al. and the National High Blood Pressure Education Program Coordinating Committee. The seventh report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension. 2003;42:1206 -1252.
(9) Kearney et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005; 365: 217-223.
(*) Norvasc is a registered trademark of Pfizer Inc.
Source: Novartis Pharmaceuticals
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