Novartis gains EU approval for combo drug Rasilamlo to treat high BP

Swiss drug major Novartis (NOVN: VX) says 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 (aliskiren), with the widely used calcium channel blocker amlodipine and was recommend for approval earlier this year by the European Medicines Agency advisory body (The Pharma Letter February 21).

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