Pharmaceutical submits NDA for new hypertension treatment

An NDA has been submitted for a new treatment targeting hypertension

A Japanese pharmaceutical has submitted a new drug application to the ministry of health, labour and welfare for a treatment of hypertension.
 
Takeda Pharmaceutical made the application for its fixed-dose combination (FDC) of Azilva tablets and amlodipine besylate.
 
Azilva is a lasting angiotensin II receptor blocker that lowers blood pressure by inhibiting the action of angiotensin II, a vasopressor hormone.
 
Amlodipine besylate, on the other hand, is a calcium channel blocker that works by blocking inward calcium ion channels mainly in vascular smooth-muscle cells.
 
A multi-centre, randomised, double-blind controlled phase 3 clinical trial was carried out on 568 patients with mild and moderate hypertension to determine the efficacy of the FDC treatment.
 
This was compared with monotherapy of either Azilva or amlodipine besylate, with the FDC therapy found to have a safety and tolerability profile comparable to each of the monotherapies.
 
It is expected that if the FDC is approved, it will help with the control of hypertension, which is a major risk factor for a heart attack, stroke or kidney disease.