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EU approves Edarbi (Takeda) for Hypertension

09 Dec 2011

The European Commission has approved the once-daily angiotensin receptor blocker (ARB) Edarbi (azilsartan medoxomil) from Takeda for Essential Hypertension. The approval is based on seven Phase III trials involving nearly 6,000 patients where the drug showed its superiority to placebo and the highest approved doses of two commonly-prescribed ARBs, Benicar (olmesartan) from Daiichi Sankyo and Diovan (valsartan)from Novartis. The drug will be launched in Germany early in 2012 and is seen as the successor to candesartan whose patent will expire in 2012. Edarbi is already FDA approved.