The European Commission has granted marketing authorisation for Edarbi® (azilsartan medoxomil), a new once-daily angiotensin receptor blocker (ARB) for the treatment of essential hypertension in adults.
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.
“We have been treating hypertension for decades with numerous different treatment regimens, yet achieving sufficient 24 hour blood pressure control, with the associated beneficial effects on cardiovascular morbidity and mortality still remains a challenge,” said Professor Neil Poulter, Professor of Preventive Cardiovascular Medicine at Imperial College London.
“Any new treatment option that can improve effective BP control will be well received, and will help to reduce the huge health burden due to the adverse effects on cardiovascular events which raised BP currently causes.”
Manufacturers Takeda will launch azilsartan medoxomil across Europe in 2012, starting with Germany in January.