The European Medicines Agency’s (EMA) acceptance of the marketing authorization application (MAA) of peginesatide has triggered the milestone.
Peginesatide, indicated to treat anemia associated with chronic kidney disease (CKD) in adult patients on dialysis, was discovered by Affymax.
If approved, peginesatide will be co-marketed by Affymax and Takeda in the US. Takeda has commercialization rights in the European Union.
Affymax president and CEO John Orwin said the company is encouraged by the EMA acceptance of the MAA.
"While we are concurrently preparing for potential commercialization of peginesatide in the United States, we are pleased that progress is being made to potentially make the product available outside the US," Orwin added.