Takeda’s peginesatide accepted for review by EMA

Takeda's new treatment for symptomatic anaemia associated with chronic kidney disease has been accepted for European Medicines Agency (EMA) review.

The company's marketing authorisation application (MAA) for peginesatide, which is intended for adult patients undergoing dialysis, was accepted earlier this month, with positive data from two phase III trials supporting the submission.

Peginesatide is a synthetic PEGylated peptidic compound that stimulates increased formation of red blood cells by binding to and activating the erythropoietin receptor, thus acting as an erythropoiesis stimulating agent.

The compound was discovered by Affymax, which will be co-marketing the drug in the US if approved, though Takeda holds sole European rights.

Dr Stuart Dollow, managing director for Takeda's global research and development centre in Europe, said: "We are committed to bringing new treatments to patients with unmet needs and look forward to working with the EMA as they review the data package for the peginesatide MAA."

Last month, the company published positive new trial data for a developmental therapy called vedolizumab, which is designed for sufferers of moderate to severely active ulcerative colitis.