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EU approval for Takeda's once-daily hypertension drug Edarbi

Japan-based company to launch the high blood pressure treatment across Europe in 2012

Takeda's hypertension treatment Edarbi (azilsartan medoxomil) has been granted marketing authorisation by the European Commission (EC).

The drug, an angiotensin receptor blocker (ARB), has been licensed as a once-daily treatment for high blood pressure in adults.

The approval was based on data from a development programme that included seven phase III clinical trials involving nearly 6,000 patients.

In comparison trials with the rival ARBs, Daiichi Sankyo's Olmetec (olmesartan medoxomil) and Novartis' Diovan (valsartan), as well as the ACE inhibitor ramipril, use of Edarbi resulted in significantly greater reductions in average 24-hour and clinic systolic blood pressure. All medicines were used at their highest recommended dose.

Reported side effects included dizziness, diarrhoea and increased blood creatinine phosphokinase, which can lead to damage to the heart, the brain, or muscle tissue.

But recommending the drug's approval advisors at the Committee for Human Medicinal Products (CHMP) said there was still a “favourable benefit-to-risk balance for Edarbi”.

This was despite “uncertainties” regarding the dosing and safety of Edarbi in complicated patients, such as the people over 75 years old, patients with a history of heart failure and patients with renal and liver insufficiency.

Edarbi was approved in the US in February. Its new license will add another option for doctors in the already crowded hypertension market in Europe, where around 44 per cent of adults are affected by high blood pressure.

Top selling products in the therapy area include Diovan, which had revenues of $2.5bn for Novartis in 2010, but recently lost patent protection, paving the way for generic competition and Takeda's own  candesartan cilexetil (marketed as Amias and Blopress in Europe), which made $2.8bn last year.

9th December 2011

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