The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in approximately three months.
"We are delighted with the CHMP opinion because it means that Rasilamlo could soon be made available to patients in the EU in need of effective combination treatments to help control their high blood pressure," said David Epstein, Division Head of Novartis Pharmaceuticals. "Novartis understands the complex needs of high blood pressure patients and is committed to furthering cardiovascular research and to developing innovative and effective treatments."
The CHMP positive opinion of Rasilamlo is 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 Rasilez 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 Rasilez 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 (systolic blood pressure [SBP] 160 - 200 mmHg), Rasilamlo demonstrated significantly greater reductions in systolic and diastolic blood pressures when compared to amlodipine alone. In one study of 443 patients, the systolic/diastolic treatment difference between Rasilez 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 Rasilez and amlodipine was 7.1/3.8 mmHg at endpoint.
The single-pill combination Rasilamlo works to lower blood pressure in two ways. The Rasilez component targets the activity of the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure. Rasilez 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.
"Single-pill combination therapies can simplify the challenging treatment regimens of high blood pressure patients on multiple medications," said Professor Gordon McInnes, Professor of Clinical Pharmacology, Institute of Cardiovascular & Medical Sciences, University of Glasgow. "Rasilamlo demonstrated greater blood pressure reductions than either aliskiren or amlodipine alone in clinical studies and can be expected to provide a convenient new treatment option to consider for uncontrolled patients."
It is estimated that about one billion people globally have high blood pressure,, and many of these remain either untreated or treated but 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. Rasilez received approval in Canada in June 2008, Japan in July 2009 and China in March 2010. Tekturna HCT®, a single-pill combination of aliskiren and hydrochlorothiazide (HCT), 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 for add-on and replacement therapy 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(TM), the single-pill combination of aliskiren and amlodipine was approved in the US in August 2010. Amturnide(TM), the triple-combination of aliskiren, amlodipine and hydrochlorothiazide (HCTZ), was approved in the US in December 2010.
Novartis has a strong cardiovascular and metabolic portfolio, focusing on innovative treatments for high blood pressure and diabetes. These include Diovan® (valsartan), the number one selling blood pressure medication worldwide, Exforge® (valsartan/ amlodipine), a single-pill combining two leading medicines for high blood pressure; Exforge HCT® (amlodipine/valsartan/HCT); and Rasilez® (aliskiren), the first and only approved direct ennin inhibitor, and two single-pill combinations of Rasilez®, Rasilez HCT® (aliskiren/HCT) and Valturna® (aliskiren/valsartan). For the treatment of type 2 diabetes, these include Galvus® (vildagliptin, a DPP-4 inhibitor) and Eucreas® (vildagliptin and metformin).
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 119,000 full-time-equivalent associates (including 16,700 Alcon associates) and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
 Rasilamlo (aliskiren and amlodipine) Tablets DRAFT Prescribing Information. February 2011.
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