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Takeda gets EU approval for Edarbi, US backing for anaemia drug

World News | December 09, 2011


Kevin Grogan

Takeda gets EU approval for Edarbi, US backing for anaemia drug

Takeda Pharmaceutical Co has been boosted by the news that the European Commission has given the green light to the company's new blood pressure drug Edarbi.

Edarbi (azilsartan medoxomil) is a once-daily angiotensin receptor blocker (ARB) and the approval is based on seven Phase III trials involving nearly 6,000 patients. In the latter, the drug showed its superiority at 80mg/day to placebo and the highest approved doses of two commonly-prescribed ARBs, Daiichi Sankyo's Benicar (olmesartan; 40mg/day) and Novartis' Diovan (valsartan; 320mg/day) in lowering blood pressure.

Edarbi, which was approved by the US Food and Drug Administration in February, will be launched across Europe in 2012, starting with Germany in January. Trevor Smith, the company's chief in Europe and Canada, said that getting marketing authorisation for at the drug "marks an important milestone for Takeda, building on our 30-year heritage in cardiovascular disease".

Neil Poulter at Imperial College London said that “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". He added that any new treatment option that can improve effective blood pressure control "will be well received and will help to reduce the huge health burden due to the adverse effects on cardiovascular events".

FDA panel recommends peginesatide

The Edarbi approval came through a few hours after the Japanese drugmaker and its partner Affymax received the backing from advisors to the US Food and Drug Administration for the anaemia drug peginesatide,

Specifically, the agency's Oncologic Drugs Advisory Committee voted 15 to one, with one abstention, that peginesatide demonstrated a favourable benefit/risk profile for use in the treatment of dialysis patients with anaemia due to chronic kidney disease.

John Orwin, chief executive at Affymax, said that as a once-monthly treatment, peginesatide, if approved, has the potential to be an important option. The drug is a synthetic, PEGylated peptidic compound that acts as an erythropoiesis stimulating agent, the same class as Amgen’s treatments Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and Johnson & Johnson's Procrit/Eprex (epoetin alfa).

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