Symplmed Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved Prestalia® (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension. Prestalia, the first fixed-dose combination of these two medications, may be used in patients whose blood pressure is not adequately controlled on monotherapy. Prestalia may be used as initial therapy if a patient is likely to need multiple drugs to achieve their blood pressure goals.
“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,” said Erik Emerson, President and CEO of Symplmed Pharmaceuticals. “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 burden of hypertension remains very high in all countries and the combination therapy is often the only treatment option for many patients,” said Dr. Isabelle Tupinon-Mathieu, Vice President R&D, Head of the Center for Therapeutic Innovation in Cardiology at Servier. “This new combination of perindopril arginine with amlodipine besylate will definitely contribute to help these patients.”
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.
“We now have another great combination of two drugs each with an evidence based outcome history that are combined in a single pill,” said George Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial.