New drug application for Rasilez®, an innovative oral renin inhibitor to treat high blood pressure, accepted for US regulatory review
* Renin inhibitors would be the first new class of high blood pressure medicines available in more than 10 years
* US submission includes data from more than 6,000 patients on Rasilez in 34 trials
* Clinical trials showed Rasilez use as a monotherapy produced significant blood pressure reductions sustained over 24 hours
* Seeking approval use as a monotherapy and in combination with other high blood pressure medicines
Basel, April 20, 2006 - Novartis 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. European submission remains on track for 2006.
The US submission included data from more than 6,000 people with high blood pressure. These data showed that when used alone, Rasilez produced significant blood pressure reductions sustained over 24 hours.1
“The sustained 24-hour blood pressure control achieved with once-daily Rasilez is good news for people with high blood pressure,” said Dr. James Shannon, MD, Head of Development at 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. Rasilez was well tolerated when used with the most common cardiovascular and anti-diabetic medicines.
“We continue to need new therapeutic approaches to control blood pressure,” said Dr. 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
Rasilez, developed with Speedel, is 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).
About high blood pressure
High blood pressure - and its consequences - is the world’s No. 1 killer and is estimated by the American Heart Association to affect one in four adults - around one billion people globally.2 Despite extensive use of current therapies, about 70% of all people with high blood pressure do not reach target blood pressure levels. Many people require three or more medicines to control their blood pressure.3 Meanwhile, many existing treatments fail to provide sustained 24-hour blood pressure control, particularly during the early morning hours.
The trade name Rasilez is currently pending regulatory, including FDA, approval.
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 “would”, “has the potential to redefine,” “potential long-term benefits,” or similar expressions, or by express or implied discussions regarding the potential regulatory approval of Rasilez, or potential future revenue from Rasilez. 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 any current or future regulatory filings will satisfy the FDA’s or other health authorities’ requirements, that Rasilez will be approved for any indications in any market, that Rasilez will be brought to market in the US or in any other country, nor that it will reach any particular sales levels. In particular, management’s expectations regarding the approval and commercialization of Rasilez could be affected by, among other things, additional analysis of 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 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 AG (NYSE: NVS) is 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.
1. Data on file: Novartis study SPP100 A2308
2. American Heart Association. International Cardiovascular Disease Statistics fact sheet. www.americanheart.org
3. Datamonitor, Treatment algorithms. Hypertension, 2003
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