FDA backs Affymax and Takeda drug Omontys for anemia due to CKD

The US Food and Drug Administration yesterday approved Omontys (peginesatide, formerly known as Hematide) Injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis, under development by USA-based Affymax (Nasdaq: AFFY) and licensee Japanese drug major Takeda Pharmaceuticals (TYO: 4502).

Omontys is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia to be made available to the dialysis patient population in the USA and is the first new drug for anemia to be approved by the FDA in over a decade.

It would compete with blockbuster drugs such as Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), as well as Johnson & Johnson's Procrit (epoetin alfa) in patients with chronic renal failure. The European Medicines Agency earlier this year accepted Takeda’s once-monthly peginesatide for review.