FDA approves Symplmed’s hypertension drug Prestalia

Prestalia is the first fixed-dose combination of perindopril arginine and amlodipine, may be used in patients whose blood pressure is not adequately controlled on monotherapy.

The drug may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.

Symplmed Pharmaceuticals president and CEO Erik Emerson said: "This is a significant milestone for Symplmed and for our development partner Servier as it is the first product from our perindopril pipeline to receive FDA approval.

"With ACE inhibitors and calcium channel blockers being two of the most highly prescribed products for the treatment of cardiovascular disease, we are excited to be able to provide physicians and patients these two therapeutic classes in a single pill combination right from the start of the treatment for hypertension."

The approval was based on data from the 837-patient Phase III PATH trial, which showed that this fixed-dose combination in a single pill was better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment.

The trial also suggested that the combination may provide a better benefit/risk ratio than either treatment alone.