Takeda’s blood pressure treatment Edarbi approved
pharmafile | December 9, 2011 | News story | Sales and Marketing | Diovan, Eisai, cardiovascular, high blood pressure, hypertension
Takeda’s new hypertension treatment Edarbi has been approved in Europe.
Edarbi (azilsartan medoxomil) is a new once-daily angiotensin receptor blocker (ARB) for the treatment of essential hypertension in adults.
The new drug is a very late addition to the ARB class – the first drug in the class, Merck’s Cozaar, was launched as long ago as 1995.
But trials show Edarbi is more effective at lowering blood pressure than most existing treatments, such as existing ARBs’, Novartis’ Diovan (valsartan) and Daiichi Sankyo’s Benicar (olmesartan) and ACE inhibitor ramipril.
Takeda will launch the drug 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 approval is based on data 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 Benicar (40mg/day), Diovan (320mg/day) and 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, National Heart and Lung Institute at Imperial College London, and said any new effective treatment was welcome.
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