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Takeda gains approval for hypertension drug Azilva in Japan

Regulators approve its once-daily angiotensin II receptor antagonist to treat high blood pressure

Takeda Pharmaceutical has won approval in Japan to market its once-daily angiotensin II receptor antagonist Azilva as a treatment for high blood pressure.

Azilva (azilsartan medoxomil) is a late entrant into the crowded angiotensin receptor blocker (ARB) category, which has already seen some lead drugs in the category, including losartan and valsartan, lose patent protection and face generic competition.

Takeda believes there is still a place for Azilva, as it offers full 24-hour control of blood pressure from a single 20mg or 40mg tablet and has been shown to outperform other drugs in the ARB class in clinical trials, including its own Blopress (candesartan cilexetil) product which is partnered with AstraZeneca.

In trials, Azilva was statistically superior to Blopress in lowering the change from baseline in sitting diastolic blood pressure, and also in lowering the mean diastolic blood pressure and systolic blood pressure over a 24-hour period.

Prior studies had also shown it to be superior to valsartan, developed and sold by Novartis as Diovan, and Daiichi Sankyo's Benicar/Olmetec (olmesartan).

Analysts have suggested that this profile could allow Azilva to achieve global sales of $700m-plus at peak.

The drug was approved in the US in February 2011 under the Edarbi brand name and a combination product based on azilsartan and the diuretic chlorthalidone was also filed for approval in the US last year.

Meanwhile in Europe, where is also marketed as Edarbi, azilsartan won approval in December 2011, despite regulatory advisors highlighting “uncertainties” regarding its dosing and safety in complicated patients.

These included people over 75 years old, patients with a history of heart failure and patients with renal and liver insufficiency, but the Committee for Human Medicinal Products (CHMP) concluded Edarbi still had a “favourable benefit-to-risk balance.

23rd January 2012

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