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news.Takeda Global Research & Development Centre (Europe) has filed a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for azilsartan medoxomil (development code: TAK-491) as a treatment for essential hypertension.
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Azilsartan medoxomil is a prodrug of the active moiety azilsartan, which lowers blood pressure by blocking the action of a vasopressor hormone, angiotensin II, Takeda said.
Azilsartan medoxomil MAA was based on the positive results from a Phase 3 clinical trials, in which approximately 7000 subjects with essential hypertension were enrolled of whom 4814 unique subjects received at least 1 dose of azilsartan medoxomil.
Results from the phase 3 clinical trials showed azilsartan medoxomil successfully met the primary endpoints and key secondary endpoint.
Takeda Global Research & Development Centre (Europe) Clinical Science head and vice president Suhail Nurbhai said that based on the encouraging results of phase 3 clinical studies demonstrating the compound’s efficacy, safety and tolerability, they believe azilsartan medoxomil, once approved, will provide clinicians in Europe with an important additional treatment for patients with essential hypertension.