Novartis gains positive CHMP opinion for Rasilamlo, as do CSL Behring for Hizentra and Provepharm for Proveblue

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Swiss drug major Novartis’ (NOVN: VX) Rasilamlo (aliskiren and amlodipine) to treat high blood pressure patients not adequately controlled by either aliskiren or amlodipine alone. Rasilamlo combines in a single pill the only approved direct renin inhibitor worldwide, Rasilez, with the widely used calcium channel blocker amlodipine. The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in around three months.

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 endpoint1.