Takeda’s Edarbi receives European marketing authorisation for the treatment of essential hypertension
Takeda Pharmaceutical Company Limited announced that the European Commission has granted marketing authorisation for Edarbi® (azilsartan medoxomil), a new once-daily angiotensin receptor blocker (ARB) (also known as angiotensin II receptor antagonist [AIIRA]) for the treatment of essential hypertension (high blood pressure) in adults. Takeda will launch azilsartan medoxomil across Europe in 2012 starting with Germany in January.
“The marketing authorisation for azilsartan medoxomil marks an important milestone for Takeda, building on our 30-year heritage in cardiovascular disease and reinforcing our commitment to expand the boundaries of hypertension treatment, address unmet needs and ultimately optimise patient outcomes across Europe,” said Trevor Smith, Head of Europe and Canada. “We believe azilsartan medoxomil provides clinicians with a highly effective new option for patients with essential hypertension.”
The marketing authorisation follows a positive opinion from the Committee for Human Medicinal Products (CHMP) based on the results from an extensive pre-clinical and clinical development programme, including seven phase III clinical trials involving nearly 6,000 patients with essential hypertension. Pivotal phase III studies showed that the highest approved dose of azilsartan medoxomil (80mg/day) resulted in significantly greater reductions in mean 24-hour and clinic systolic blood pressure than the highest approved doses of the ARBs olmesartan medoxomil (40mg/day), valsartan (320mg/day) and the ACE inhibitor ramipril (10mg/day). In clinical studies, adverse reactions associated with treatment with azilsartan medoxomil were mostly mild or moderate, with an overall incidence similar to placebo. The most commonly observed treatment-related adverse reactions were dizziness, increased blood creatine phosphokinase and diarrhoea.
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