Drug is separately under review by the European Medicines Agency.
Affymax and partner Takeda Pharmaceutical confirmed FDA approval of Omontys® (peginesatide) injection for the treatment of anemia in adult chronic kidney disease (CKD) patients on dialysis. The firms say the drug is the only once-monthly erythropoiesis-stimulating agent (ESA) approved for use in dialysis patients in the U.S.
FDA clearance was based on data from two randomized Phase III studies, Emerald 1 and 2, which demonstrated that compared with 1–3 times weekly epoetin treatment, Omontys was as safe and effective at maintaining hemoglobin levels in CKD patients on dialysis. The Phase III program involved 2,606 participants, including 1,600 dialysis patients.
FDA’s approval of Omontys comes with the requirement for post-marketing studies to evaluate the cardiovascular safety and long-term safety of Omontys, and new pediatric studies. A Risk Evaluation and Mitigation Strategy has been established to warn that use of Omontys in patients with CKD who aren’t on dialysis may be at an increased risk of specific cardiovascular events, as evidenced by two prior clinical trials.
Omontys is a synthetic, pegylated peptide-based ESA originally discovered by Affymax. The drug will be co-commercialized in the U.S. by the two firms. Last month Takeda confirmed that its Marketing Authorization Application (MAA) for peginesatide had been accepted by the European Medicines Agency and is currently under review.