CINCINNATI - Symplmed announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational drug Prestalia®, the first single-pill, fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension in the U.S. Symplmed filed the application under section 505(b)(2) consistent with FDA’s guidance. The Prescription Drug User Fee Act (PDUFA) goal date for Prestalia is January 21, 2015.
Perindopril is a well-known, long-acting angiotensin-converting enzyme (ACE) inhibitor indicated for hypertension and stable coronary artery disease. Amlodipine, the number one prescribed anti-hypertensive, is a calcium channel blocker indicated for the treatment of hypertension and coronary artery disease. Servier, a leading French private pharmaceutical research company and development partner to Symplmed, currently markets a single-pill combination treatment as Coveram ® in 84 countries outside the United States. Prestalia is the first and only single-pill, fixed-dose combination of these two important medicines to be reviewed by theFDA to date.
“Acceptance of our NDA is an important corporate milestone for Symplmed as Prestalia will be our first proprietary product with regulatory exclusivity,” said Erik Emerson, president and CEO of Symplmed. “Phase III data showed that Prestalia provided rapid and sustained blood pressure control in one convenient pill. We look forward to working with the FDA throughout the review process.”
The Prestalia NDA is primarily supported by data from the 837-patient Phase III PATH trial ( P erindopril Amlodipine for the T reatment of H ypertension) which demonstrated that the single pill of perindopril arginine combined with amlodipine besylate was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment.
“The clinical outcomes from the Phase III PATH study suggest that Prestalia could offer an effective as well as convenient option for patients,” said George L. Bakris, MD, former president of the American Society of Hypertension and principal investigator for the PATH trial. “The clinical study also indicated that the combination may provide a better benefit/risk ratio than either treatment alone. A single-pill, fixed-dose combination of perindopril arginine and amlodipine besylate would be a welcome addition to our treatment options.”