Takeda to apply for regulatory approval of Hematide

Takeda has outlined its plans to apply for regulatory approval of its collaboratively-developed anaemia treatment Hematide within the next year.

The company, in association with partner Affymax, has committed to conducting further in-depth analysis of data from the recent phase III Pearl and Emerald studies of the drug, which is designed for chronic renal failure patients.

Results announced from these trials thus far have been positive, demonstrating the drug’s non-inferiority when compared to epoetin and darbepoetin.

Takeda is to discuss findings from its research with the US Food and Drug Administration, with the intention of submitting a new drug application in the first half of 2011.

It is then hoped that Takeda can commercialise the treatment in both the EU and Japan following its US approval.

Last month, the company announced the appointment of Dr Frank Morich and Haruhiko Hirate to new roles in its international operations leadership, in order to help the company to capitalise on market growth.