Novartis Pharma has received US Food and Drug Administration (FDA) approval for Tekamlo (aliskiren and amlodipine) tablets combining with direct renin inhibitor, Tekturna (aliskiren) with amlodipine for the treatment of blood pressure.
Novartis Pharma said that the FDA approval was based on the eight-week, randomised, double-blind, placebo-controlled, multi-factorial study which showed that the combination of Tekturna and amlodipine 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.
Novartis Pharma division head David Epstein said that they 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.
"This approval reinforces the commitment of Novartis to cardiovascular research and to developing effective treatments for patients who have not reached their blood pressure goal," Epstein said.
Temple University School of Medicine professor of medicine at Alan Gradman said that 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.