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Takeda's once-monthly anaemia treatment accepted for EMA review

Japanese pharma firm also announced positive trial results for diabetes drug TAK-875

The European Medicines Agency (EMA) has accepted Takeda's once-monthly anaemia treatment peginesatide for review.

The drug, which was discovered by Affymax, is a potential new treatment for symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients on dialysis.

If approved, Takeda will market the product alone in the EU, while in the US, where a decision from the Food and Drug Administration (FDA) is expected by March, 27, the company will partner with Affymax.

Peginesatide treats the deficiency in red blood cells by binding to and activating the body's erythropoietin receptor, resulting in the increased formation of red blood cells.

The EMA approval submission is based on two phase III studies that compared peginesatide, dosed once every four weeks, to epoetin alfa or epoetin beta, dosed three times per week, in maintaining haemoglobin (Hb) levels.

The trials involved more than 2,600 patients, with data indicating that once-monthly peginesatide was similar to epoetin in maintaining Hb levels in CKD patients on dialysis with anaemia.

“Although anaemia is a debilitating condition for chronic kidney disease patients on dialysis, appropriate management of this condition is onerous for patients and healthcare professionals,” said Dr Stuart Dollow, managing director, Takeda Global Research & Development Centre (Europe).

“Our programme illustrates the potential of peginesatide as an important once-monthly therapeutic option.”

Positive results for diabetes treatment

Meanwhile, Takeda has also released data of a phase II trial involving its investigational type 2 diabetes therapy, TAK-875.

Presenting at the American Diabetes Association 71st Annual Scientific Sessions, the Japan-based pharma firm said its GPR40 agonist met the trial's primary endpoint of significantly lowering blood glucose levels over a 12-week period versus placebo.

There was also no significant increase in the incidence of hypoglycaemia compared to placebo.

“Because of its observed ability to potently stimulate insulin secretion and improve glycemic control with less or no hypoglycaemia, these data further support TAK-875 as a potential therapy for the treatment of type 2 diabetes in the future,” said Dr Thomas Strack, development therapeutic area head, metabolic, Takeda.

Phase III trials for TAK-875 are ongoing in Japan, the US, Latin America, and Europe.

27th February 2012

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