FDA Approves New Hypertension Treatment

The FDA today approved perindopril arginine and amlodipine (Prestalia) tablets for the treatment of hypertension.

Patients whose blood pressure is not adequately controlled on monotherapy may use Prestalia, the first fixed-dose combination of these 2 drugs, a FDA press release stated. Prestalia can be used as initial therapy if the patient may need multiple drugs in order to reach his or her blood pressure goals.

In a 837-person study over 6 weeks, Prestalia proved to work better than just perindopril arginine or amlodipine besylate alone for reducing sitting diastolic and sitting systolic blood pressure. The FDA said the combination may provide a better benefit/risk ratio than either treatment alone. In addition, studies show that these classes of drugs may help reduce cardiovascular events, the FDA noted.

Symplmed Pharmaceuticals, Prestalia’s manufacturer, and Servier, Symplmed’s development partner, expect the treatment to be available within the first quarter of 2015 through its hypertension management program called bpCareConnect.

“The burden of hypertension remains very high in all countries, and the combination therapy is often the only treatment option for many patients,” said Isabelle Tupinon-Mathieu, vice president R&D, head of the Center for Therapeutic Innovation in Cardiology at Servier, in a press release “This new combination of perindopril arginine with amlodipine besylate will definitely contribute to help these patients.”