Novartis receives EU approval for Rasilamlo

Rasilamlo combines in a single pill the only approved direct renin inhibitor, Rasilez, with the widely used calcium channel blocker amlodipin

28-Apr-2011 - Switzerland

Novartis announced that Rasilamlo®, a single-pill combination of aliskiren and amlodipine, has received approval from the European Commission (EC) for the treatment of high blood pressure patients not controlled by either aliskiren or amlodipine alone. Rasilamlo combines the only approved direct renin inhibitor worldwide, Rasilez®, with the widely used calcium channel blocker amlodipine.

Rasilamlo has been evaluated in clinical studies involving more than 5,000 patients with mild-to-severe high blood pressure. Data shows that Rasilamlo provides greater blood pressure reductions than Rasilez and amlodipine alone.

"We are pleased to announce that following today's EC approval Rasilamlo will now be available to high blood pressure patients in the EU who are not controlled by either aliskiren or amlodipine alone," said David Epstein, Division Head of Novartis Pharmaceuticals. "This approval reinforces the Novartis commitment to developing new treatment options for patients with uncontrolled high blood pressure."

Data shows that up to 85% of patients will require more than one therapy to best manage their blood pressure. However, increasing the number of medications a patient is required to take can have a negative impact on their compliance to therapy. Studies suggest that on average only 8% of patients with high blood pressure in the EU have their condition under control, suggesting that the use of single-pill combinations like Rasilamlo can provide a convenient new treatment option for patients with uncontrolled blood pressure.

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.

https://www.bionity.com/en/news/132123/novartis-receives-eu-approval-for-rasilamlo.html