【商业翻译—医师报约稿】Rasilez, An Important New
Rasilez, An Important New Treatment For High Blood Pressure, Receives Positive Opinion Recommending European Union Approval
Main Category: Hypertension News
Article Date: 24 Jun 2007 - 0:00 PDT
Novartis has received a positive opinion recommending European Union approval of Rasilez (aliskiren) as the first new type of high blood pressure treatment in more than a decade.
The Committee for Medicinal Products for Human Use (CHMP), which reviews medicines for the European Commission, issued the positive opinion for Rasilez based on data from more than 7,800 patients in 44 clinical studies. The Commission generally follows the CHMP's recommendations and is expected to issue a decision within three months.
The clinical trial program showed that Rasilez provided significant blood pressure reductions for 24 hours and beyond3. Furthermore, Rasilez provided added efficacy when used in combination with other commonly used blood pressure medications,.
Studies estimate that nearly one billion people may have high blood pressure and that nearly 70% of patients with high blood pressure never reach healthy blood pressure levels. As a result, they live at risk of complications like heart attack, stroke, blindness and premature death, creating a strong need for new therapies like Rasilez,,.
"This important milestone for Rasilez comes just days after the US approval of Exforge as our new fixed combination therapy. Following the anticipated EU approval of Rasilez, our new antihypertensive medicines will be made available to patients in the US, Europe and elsewhere as quickly as possible. We have made significant progress in developing a broad and complementary portfolio of medicines to help physicians worldwide treat patients with high blood pressure," said Thomas Ebeling, CEO of Novartis Pharma.
Rasilez is the first in a new class of drugs called direct renin inhibitors. It acts by directly inhibiting renin, an enzyme that triggers a process leading to high blood pressure. The medication received its first approval in March 2007 from the US Food and Drug Administration under the trade name Tekturna.
"If approved, Rasilez will offer millions of Europeans an important new treatment option for high blood pressure," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "This positive opinion is highly encouraging since Rasilez has been shown to help a wide variety of people by providing long-lasting blood pressure control."
In clinical trials, the approved doses of Rasilez demonstrated a placebo-like tolerability profile4. Rasilez was developed in collaboration with Speedel.
Blood pressure measurements consist of two values: the first represents the pressure within blood vessels when the heart contracts, while the second represents the pressure when the heart is at rest between beats. Blood pressure is measured in millimeters of mercury (mmHg), with normal blood pressure levels between 120/80 mmHg and 140/90 mmHg.
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as "generally follows," "anticipated," "will," "expected," "may," "estimate" or similar expressions, or by express or implied discussions regarding the potential regulatory approval of Rasilez or future sales of Rasilez. Such forward-looking statements reflect the current views of Novartis regarding future events and 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 Rasilez will be approved for any indications or brought to market in the European Union or in any other market or that Rasilez 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; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; as well as other risks and factors referred to in Novartis AG's 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.
作者:admin@医学,生命科学 2011-02-16 05:11