יותר מ-3,000 חולים סובלים מהתקף לב בארה”ב כל יום. למרות ההתקדמות בשנים האחרונות, מוות מהתקף לב נשאר גבוה במיוחד. מחקר VALsartan In Acute myocardial iNfarcTion כלל יותר מ-14,000 חולים ב-24 מדינות.

יתר לחץ דם, מחלה המשפיעה על מיליארד חולים בעולם, מעלה בצורה ניכרת את הסיכון להתקף לב או אי ספיקת לב. אנשים שעברו התקף לב נמצאים בסיכון גדול יותר לאירועים נוספים או תמותה ועלולים לסבול מאי ספיקת לב. בתוך 6 שנים כמעט שליש מאלו ששרדו התקף לב יסבלו מאי ספיקת לב, מצב בו שריר הלב נחלש לאחר פגיעה ממצב קרדיווסקולרי אחר כמו התקף לב או יתר לחץ דם.

בהתבסס על התוצאות, ולסרטן הראתה יתרונות נוספים שיוכלו לענות על צרכיהם של מגוון רחב של חולי לב. אישור ולסרטן להפחתת תמותה קרדיווסקולרית בחולים בסיכון גבוה לאחר התקף לב מבוססות על תוצאות מחקר VALIANT. במחקר הערכה בשוואה בין ולסרטן לקפטופריל (מעכב ACE) לעומת שילוב של שניהם ב-14,703 חולים בסיכון גבוה לאחר התקף לב. ולסרטן שיפר שרידות והפחית אירועי לב כולל חזרת המחלה ואישפוזים בשל ספיקת לב. לא היו הבדלים בתמותה בים קבוצות הטיפול. התוצאות פורסמו ב-New England Journal of Medicine.

 להלן נוסח ההודעה המקורי המלא כפי שהועבר אלינו ע”י נוברטיס:

Novartis receives FDA approval for Diovan® (valsartan) to reduce cardiovascular death in heart attack survivors at high risk

First-in-class approval for powerful high blood pressure agent follows authorizations across EU and worldwide for both heart attack survivors and people with heart failure

Basel, August 4, 2005 Novartis announced today that the US Food and Drug Administration (FDA) approved Diovan® (valsartan), the most prescribed ARB (angiotensin receptor blocker) worldwide, for a new indication to reduce cardiovascular death in patients at high risk (with left ventricular failure or left ventricular dysfunction) following a heart attack.  The FDA also expanded the drugs heart failure labeling. Diovan can now be prescribed in a broader range of heart failure patients and is no longer limited to those intolerant of ACE inhibitors.

Diovan is now the only agent in its class across the world indicated to treat high blood pressure, high-risk heart attack survivors and people with heart failure.  The US approval follows shortly after marketing authorizations were granted for Diovan in 14 EU member states and other countries around the world to treat people who survived a recent heart attack and people with heart failure. 

“Every day, more than 3,000 patients suffer a heart attack in the United States.[1]  While weve made significant advances in recent years, death following a heart attack remains unacceptably high,” said Marc Pfeffer, MD, PhD, professor of medicine at Harvard Medical School, interim chair of medicine at Brigham and Womens Hospital, Boston, and the chair of the VALIANT (VALsartan In Acute myocardial iNfarcTion) trial, the study that led to the FDAs approval.  “VALIANT was a tremendous scientific undertaking involving more than 14,000 patients in 24 countries.  We are proud it has resulted in the approval of a new treatment to help improve the survival of patients at high risk following a heart attack.”

High blood pressure, a disease which affects one billion people globally[2], greatly increases the risk of suffering a heart attack or developing heart failure.  People who have suffered a heart attack are at greater risk of repeat attacks or death and may also progress to heart failure.  In fact, within six years, nearly one-third of heart attack survivors will be disabled with heart failure, a progressive condition in which the heart’s muscle weakens after injury from other cardiovascular conditions such as a heart attack or high blood pressure.

“Millions of patients already rely on Diovan to help them get to goal and maintain healthier blood pressure goals.  Now, based on results from one of the largest megatrial programs in the ARB class, Diovan has demonstrated additional benefits that can address the needs of an even broader spectrum of cardiovascular patients,” said Joerg Reinhardt, Head of Development, Novartis Pharma AG.  “We remain committed to developing the full clinical potential of this agent.”

Approvals based on landmark VALIANT trial

The approvals of Diovan to reduce cardiovascular death in high-risk heart attack survivors are based on the results of VALIANT, one of the largest, long-term studies ever conducted in people who have suffered a heart attack.  VALIANT was a rigorous comparison of Diovan vs. captopril (an ACE inhibitor) vs. the combination of both in 14,703 patients at high risk for death following a heart attack.  In the VALIANT trial Diovan was reported to improve survival and reduce cardiovascular events including recurrent heart attack and hospitalizations for heart failure in these patients.  There were no differences observed in overall mortality among the treatment groups.  The results of VALIANT were published in the peer-reviewed journal, the New England Journal of Medicine, and presented at the American Heart Association Scientific Sessions in November 2003.[3]

About Diovan

Novartis remains on the forefront of cardiovascular medicine, through development of innovative products like Diovan, one of the most prescribed antihypertensives in the world today.  Diovan is available as a powerful first-line treatment for high blood pressure in more than 90 countries, for the treatment of heart attack survivors in nearly 50 countries and in 70 countries for the treatment of people with heart failure.  Additional marketing authorization applications are pending for the treatment of post-heart attack and heart failure.

For high-risk heart attack patients, Diovan recently completed the EU Mutual Recognition Procedure (MRP) in 14 countries for the treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent myocardial infarction.  In the US, Diovan is indicated to reduce cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction.

For heart failure, Diovan also completed an EU type II variation application in 14 countries for the treatment of people with symptomatic heart failure when ACE inhibitors can not be used, or as add-on therapy to ACE inhibitors when beta blockers can not be used.  In the US, Diovan is indicated for the treatment of heart failure (NYHA class II-IV).

Novartis is committed to improving research, especially in cardiovascular and metabolism care.  The Diovan clinical trial program represents one part of this commitment, involving more than 50,000 patients across the cardiovascular continuum.  Recently completed Diovan megatrials include VALUE in hypertension patients at high-risk for cardiovascular complications, VALIANT in post-heart attack patients and Val-HeFT in heart failure patients.  Ongoing studies include NAVIGATOR, the largest outcomes trial ever conducted on the delay or prevention of cardiovascular events and type II diabetes in patients with impaired glucose tolerance.

The foregoing release contains forward-looking statements that can be identified by terminology such as “potential,” “are pending” or similar expressions, or by express or implied discussions regarding potential new indications or labeling and marketing approvals for Diovan or Co-Diovan or regarding potential future sales of Diovan or Co-Diovan.  Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Diovan or Co-Diovan to be materially different from any future results, performance or achievements expressed or implied by such statements.  There can be no guarantee that Diovan or Co-Diovan will be approved for any additional indications or labeling in any other market.  Nor can there be any guarantee regarding potential future sales of Diovan or Co-Diovan.  In particular, management’s expectations regarding commercialization of Diovan or Co-Diovan could be affected by, among other things, additional analysis of Diovan or Co-Diovan 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; industry, government, and general public pricing pressures; and other risks and factors referred to in the Company’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.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group’s businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

#   #   #

Contacts:

Eric Althoff

Novartis Pharma Communications

+41 (61) 324 6392 (direct)

+41 (79) 593 4202 (mobile)

eric.althoff@novartis.com

John Gilardi

Novartis Global Media Relations

+41 61 324 3018 (direct)

+41 79 596 1408 (mobile)

john.gilardi@novartis.com

References: