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news.Daiichi Sankyo has filed a supplemental new drug application with the FDA for the combination treatment Azor as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goal.
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The supplemental new drug application (sNDA) filing was based upon data from the pivotal registrational trial, which provided estimates of the probability of patients attaining blood pressure goals with Azor compared to amlodipine or olmesartan medoxomil alone.
Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents. Presently, Azor is not indicated for the initial therapy of hypertension. Azor may be substituted for its individually titrated components. Azor may also be used to provide additional blood pressure lowering for patients not adequately controlled with any calcium channel blocker or any angiotensin receptor blocker alone, the company said.
William Sigmund II, vice president of medical affairs at Daiichi Sankyo, said: “Given the prevalence of patients with high blood pressure, the approval of Azor as initial therapy would give physicians a valuable treatment option to help more patients reach their blood pressure goal.
“Research and innovation in cardiovascular care is a therapeutic focus for Daiichi Sankyo, and expansion of Azor’s label is in line with our vision to contribute to the health of people in the US.”