Affymax, Inc. and Takeda Global Research & Development Centre, Inc., US, announced that the US Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for peginesatide (formerly known as Hematide) for the treatment of anaemia associated with Chronic Kidney Disease (CKD) in adult patients on dialysis.

If approved, peginesatide will be the first once-monthly Erythropoiesis Stimulating Agent (ESA) available for the treatment of anaemia associated with CKD patients on dialysis in the United States.

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA. The NDA included data from two phase III studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels) in maintaining haemoglobin (Hb) levels. In the studies, over 1,600 CKD patients on dialysis who were receiving  stable doses of epoetin were randomized to receive once-monthly peginesatide or continue treatment with epoetin.

The EMERALD findings suggested that once-monthly peginesatide was comparable to epoetin in maintaining Hb levels in CKD patients on dialysis with anaemia with a similar adverse event rate. The most common adverse events reported in the clinical studies were diarrhoea, cough, dyspnea, nausea, and muscle spasm. A similar frequency of serious adverse events was reported between the EMERALD treatment groups.

Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States. The product, upon approval, will be commercialized outside the United States by Takeda. The peginesatide phase III clinical programme was the largest to support the registration of an ESA for the treatment of anemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events.

Anaemia is a common complication in CKD, because the impaired kidneys are not able to produce enough erythropoietin, the hormone that promotes the production of oxygen-carrying red blood cells.

Research has shown that anaemia impacts the overall health and well being of CKD and dialysis patients and is associated with increased rates of hospitalization and mortality.

In severe or prolonged cases of anaemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs.

ESAs, which stimulate red blood cell production, are commonly prescribed to treat anaemia of CKD.

According to the Centres for Medicare and Medicaid Services, more than 95 percent of patients on dialysis in the US are currently receiving ESA treatment for anaemia of CKD.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Centre, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology and cardiovascular disease treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, gastroenterology, neurology and other conditions.