FDA approves Prestalia for Hypertension-Symplmed Pharma

The FDA has approved Prestalia (perindopril arginine and amlodipine) tablets, from Symplmed Pharmaceuticals and licensed from Servier, for the treatment of hypertension. FDA approval of Prestalia was based on data from the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension).

The study demonstrated that the fixed-dose combination of perindopril arginine with amlodipine besylate in a single pill was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. It also suggested that the combination may provide a better benefit/risk ratio than either treatment alone. There are additional clinical studies that demonstrate use of these classes of drugs together may reduce cardiovascular events.