Affymax Inc. (AFFY) and Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration or FDA approved OMONTYS (peginesatide) Injection for the treatment of anemia due to chronic kidney disease or CKD in adult patients on dialysis.
Affymax stated that OMONTYS is the only once-monthly erythropoiesis-stimulating agent or ESA for anemia to be made available to the dialysis patient population in the United States.
Affymax said that in the approval action letter, the FDA outlined post-marketing requirements: an observational study and a randomized controlled trial to be completed with final reports submitted in 2018 and 2019, respectively.
The objectives of the studies are to evaluate cardiovascular safety and assess safety of long-term use in adult patients on dialysis, in particular in the incident patient population. In addition, the post-marketing commitment includes the initiation of pediatric studies with target dates for completion between 2016 and 2027, the company said.
The company noted that letters will be sent to nephrology healthcare providers as part of a Risk Evaluation and Mitigation Strategy (REMS) to inform them that OMONTYS is not indicated in patients with CKD not on dialysis. In two trials of OMONTYS, patients with CKD not on dialysis experienced increased specific cardiovascular events.
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