Novartis Pharmaceuticals Corporation Release: New Drug Application (NDA) For Rasilez(R) (Aliskiren), An Innovative Oral Renin Inhibitor To Treat High Blood Pressure, Accepted For Review By The US FDA
EAST HANOVER, N.J., April 20 /PRNewswire/ -- Novartis Pharmaceuticals Corporation announced today that the US Food and Drug Administration (FDA) accepted its application for Rasilez (aliskiren) as a treatment for high blood pressure. As a renin inhibitor, Rasilez would represent the first new treatment approach for people with high blood pressure in more than a decade.
The Rasilez application includes data from more than 6,000 people with high blood pressure. Data from the Rasilez application showed that when used alone Rasilez produced significant blood pressure reductions sustained over 24 hours. Sustained blood pressure reductions throughout the day, especially in the early morning when blood pressure surges occur, is a potentially important benefit.
"The sustained 24-hour blood pressure control achieved with once-daily Rasilez is good news for people with high blood pressure," said James Shannon, MD, Head of Development, Novartis Pharma AG. "This innovative medicine has the potential to redefine future treatment standards, and studies are now underway to evaluate potential long-term benefits beyond blood pressure control."
Throughout the clinical program, Rasilez showed placebo-like tolerability when used alone. When used with ACE inhibitors, calcium channel blockers, or a diuretic, Rasilez delivered additional blood pressure reductions, helping people already on therapy to reach their blood pressure goals. In clinical studies, Rasilez was well tolerated when used with the most common cardiovascular and diabetic medications.
"We continue to need new therapeutic approaches to control blood pressure," said Michael Weber, MD, Professor of Medicine at SUNY Downstate Medical Center in New York. "Renin inhibition has long been considered a logical and highly desired treatment approach. The Rasilez data show that inhibiting renin directly is effective in reducing blood pressure, and in this case, over 24 hours."
Renin inhibition: a unique mechanism of action
If approved Rasilez would be a first-of-its-kind treatment in the long search for effective oral renin inhibition. It acts within the Renin System, which is central to blood pressure regulation. By suppressing the system's point of activation -- renin -- Rasilez decreases the activity of the Renin System, as measured by plasma renin activity (PRA).
In the clinical trial program, Rasilez has consistently shown tolerability similar to placebo up to 300 mg (within the expected therapeutic dose range). The most commonly reported adverse events for Rasilez include diarrhea, headache and nasopharyngitis (inflammation of the nose). All drugs that act directly on the renin angiotensin system carry a warning that they should not be used in pregnant women due to the risk of injury and even death to the fetus.
About high blood pressure
High blood pressure -- and its consequences -- is the world's number 1 killer and is estimated by the American Heart Association to affect one in four adults -- around 1 billion people globally. Despite extensive use of current therapies, 70% of all people with high blood pressure do not reach target blood pressure levels. Many people require 3 or more medicines to control their blood pressure. Meanwhile, many existing treatments fail to provide sustained 24-hour blood pressure control, particularly during the early morning hours.
The tradename Rasilez(R) is currently pending regulatory, including FDA, approval.
This release contains certain "forward-looking statements" relating to Novartis Pharmaceuticals Corporation's business, which can be identified by the use of forward-looking terminology such as "would," "potential," "long- term," "expected" or similar expressions, or by express or implied discussions regarding potential marketing approvals or potential future sales of Rasilez. Such statements reflect the current views of Novartis Pharmaceuticals Corporation with respect to future events and are subject to certain risks, uncertainties and assumptions. There can be no guarantee that Rasilez will be approved for sale in any market, or that it will reach any particular sales levels. In particular, management's expectations regarding Rasilez could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including additional analysis of Rasilez clinical data, or new clinical data; 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.
About Novartis
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 AG is the only company with leadership positions in both patented and generic pharmaceuticals. Novartis AG is strengthening its 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.
Novartis Pharmaceuticals CorporationCONTACT: Christine Cascio, +1-862-778-8026 direct, +1-917-449-9982 mobile,christine.cascio@novartis.com, or Maura Bergen, +1-862-778-4146 direct,+1-917-334-0903 mobile, maura.bergen@novartis.com, both of NovartisPharmaceuticals Corporation
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