Biotech Values

[DewDiligence]

FDA Approves NVS’ Tekturna+Norvasc Combination Pill

[The drug name is Tekamlo; the “amlo” portion comes from amlodipine (generic Norvasc). NVS is already marketing a combo pill called Valturna, which consists of Diovan + Tekturna (#msg-41609619), and a combo pill called Tekturna HCT, which consists of Tekturna + hydrochlorothiazide (#msg-26156985). NVS is also developing a 3-in-1 pill consisting of Tekturna + Norvasc + HCT.]

http://www.novartis.com/newsroom/media-releases/en/2010/1440875.shtml

›August 27, 2010 07:00 CET

Novartis receives FDA approval of Tekamlo®, a single-pill combination of aliskiren and amlodipine to treat high blood pressure

• Tekamlo combines in a single-pill the only approved direct renin inhibitor, Tekturna®, with the widely prescribed calcium channel blocker, amlodipine

• Data showed Tekamlo significantly reduced blood pressure compared to amlodipine or Tekturna alone

• Up to 85 percent of patients may need multiple medications to help control their high blood pressure, underscoring the need for effective combination treatments

Basel, August 27, 2010 - The US Food and Drug Administration (FDA) today approved Tekamlo® (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna® (aliskiren) with the widely used calcium channel blocker, amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

"We welcome the FDA's decision to approve Tekamlo, as the treatment of high blood pressure remains a challenge for many patients requiring multiple medications to control their condition," said David Epstein, Division Head of Novartis Pharmaceuticals. "This approval reinforces the commitment of Novartis to cardiovascular research and to developing innovative and effective treatments for patients who have not reached their blood pressure goal."

The FDA approval of Tekamlo was based on clinical trial data involving more than 5,000 patients with mild-to-moderate high blood pressure. An eight-week, randomized, double-blind, placebo-controlled, multi-factorial study showed that the combination of Tekturna and amlodipine resulted in decreases in systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg, compared to 4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for amlodipine alone .

In two additional double-blind, active-controlled studies of similar design evaluating patients with moderate-to-severe high blood pressure (SBP 160 - 200 mmHg), Tekamlo demonstrated significantly greater reductions in systolic and diastolic blood pressures when compared to amlodipine alone . In one study of 443 Black patients the systolic/diastolic treatment difference between Tekamlo and amlodipine was 5.2/3.8 mmHg at the primary endpoint of eight weeks . In the other study of 484 patients the treatment difference between Tekamlo and amlodipine was 7.1/3.8 mmHg at endpoint .

The single-pill combination Tekamlo works to lower blood pressure in two ways. The Tekturna component targets the activity of the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure . Tekturna directly binds to and inhibits renin, an enzyme produced by the kidneys that starts a process that can make blood vessels narrow and lead to high blood pressure . The calcium channel blocker, amlodipine lowers blood pressure by relaxing the blood vessel walls through the inhibition of calcium. Both of these medicines enable blood to flow more easily therefore lowering blood pressure . The blood pressure lowering effects of Tekamlo are largely attained within one to two weeks .

"Single-pill combination therapies provide a convenient treatment option while supporting physicians in addressing the complex needs of patients," said Alan Gradman, M.D., Professor of Medicine at Temple University School of Medicine. "This new single-pill combination demonstrated greater blood pressure reductions than either drug alone in clinical studies and therefore provides a new option to consider when choosing appropriate high blood pressure therapies."

It is estimated that about one billion people globally have high blood pressure, and many of these remain either untreated or treated but are not at their blood pressure target. High blood pressure can cause damage to the vital organs of the body, including the heart, brain and kidneys. However, if high blood pressure is properly controlled, the incidence of stroke and heart failure can be reduced by almost half, and heart attacks by one quarter.

Tekturna/Rasilez® is approved in over 80 countries. Tekturna was approved in the US in March 2007 and in the European Union in August 2007 under the trade name Rasilez®. In July 2009, Rasilez also received approval in Japan. Tekturna HCT®, a single-pill combination of aliskiren and hydrochlorothiazide, was approved in the US in January 2008 for second-line treatment of high blood pressure, and in July 2009 for first-line treatment of high blood pressure. The single-pill combination Rasilez HCT® was approved in the European Union in January 2009. In September 2009, Valturna®, a single-pill combination of aliskiren and valsartan (Diovan®), was approved in the US. Tekamlo®, the single-pill combination of aliskiren and amlodipine was submitted for European approval in 2009. Other single-pill combinations with aliskiren are currently in development including a single-pill combination with amlodipine and hydrochlorothiazide.‹