Novartis has been granted EU approval for Exforge HCT, a new three-in-one treatment for high blood pressure.
Up to 85% of patients may need multiple medications to help control their blood pressure. To reduce the daily pill burden Novartis Exforge HCT combines three widely prescribed blood pressure treatments, valsartan, amlodipine and hydrochlorothiazide into a single pill.
Novartis Pharmaceuticals Division CEO Joe Jimenez said that simplified treatment regimens and reduced pill burdens would help patients improve their treatment compliance.
“We are confident that it will become an important new treatment option,” he said.
EU approval was based on the results from a multinational, randomised, double-blind, parallel-group, Phase III study designed to compare the efficacy and safety of triple therapy in patients with moderate-to-severe hypertension.
The trial, conducted on 2,271 patients showed the triple therapy to be more effective in reducing systolic and diastolic blood pressure than dual combinations of its components.
Exforge HCT was approved in the US by the Food and Drug Administration (FDA) in April 2009