NDA Accepted for Review for Fixed-Dose Combo Hypertension Drug
Symplmed announced that the FDA has accepted its New Drug Application (NDA) for review for Prestalia, a fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension.
The NDA submission was supported with data from the Phase 3 PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) in 837 patients. Results demonstrated that the combination of perindopril arginine and amlodipine besylate was significantly better than either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment.
Perindopril, a long-acting angiotensin-converting enzyme (ACE) inhibitor, is indicated for hypertension and stable coronary artery disease. Amlodipine, a calcium channel blocker, is indicated for the treatment of hypertension and coronary artery disease.
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