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Novartis blood pressure drug accepted for FDA review
Novartis has announced that it application for its new treatment for people with high blood pressure, Exforge, has been accepted for review by the FDA after a successful application with the EU.
Exforge, a combined calcium channel blocker and angiotensin receptor blocker based on the two best-selling medications for both categories, caused “significant” blood pressure reductions in patients during clinical trials. The trials involved more than 5,000 patients, including five controlled trials where one dose per day was found to be well-tolerated.
Novartis says that high blood pressure is the world’s most common cause of death but it adds that 70 per cent of Americans with high blood pressure do not have it under control.
Dr James Shannon, Novartis’ head of development, said: “With so many patients still uncontrolled, a real need exists for an agent that can help people reach and maintain their blood pressure goal.”
“Exforge has the added benefit of bringing together the efficacy of two established mechanisms of action, resulting in significantly lower blood pressure,” he added.
The Blood Pressure Association estimates that as many as 16 million Britons suffer from high blood pressure. It says that it cannot really be cured but steps can be taken to reduce it, such as reducing salt intake, eating recommended portions of fruit and vegetables, and losing weight. Patients with a blood pressure consistently in excess of 160/100mmHg are likely to be given medication, according to the association.
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