Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) today announced that pivotal Phase 3 data on the safety and efficacy of OMONTYS ® (peginesatide) Injection were published in the January 24 th issue the New England Journal of Medicine ( NEJM). These studies, known as EMERALD 1 and 2, compared OMONTYS given once monthly to epoetin administered one-to-three times per week (according to epoetin product labeling) in the treatment of anemia in adult chronic kidney disease (CKD) patients on hemodialysis.
The EMERALD studies were part of the New Drug Application (NDA) upon which the U.S. Food and Drug Administration’s (FDA) March 27, 2012 approval of OMONTYS was based. These studies evaluated the use of the medication in treating one of the common complications of CKD among dialysis patients. OMONTYS is indicated for the treatment of anemia due to CKD in adult patients on dialysis. OMONTYS is not indicated and is not recommended for use in patients with CKD not on dialysis, in patients receiving treatment for cancer and whose anemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia. OMONTYS has not been shown to improve symptoms, physical functioning, or health-related quality of life. Please see Important Safety Information including Boxed WARNINGS below.
The efficacy and cardiovascular (CV) safety assessment data published in NEJM showed:
- Noninferiority to Epoetin in Maintenance of Hemoglobin (Hb) : The difference between the OMONTYS and epoetin-treated groups in the mean change in Hb levels from baseline to the study evaluation period (calculated as the mean of all measurements during weeks 29-36) in EMERALD 1 and 2 was -0.15 g/dL (95 percent CI: -0.30, -0.01) and 0.10 g/dL (95 percent CI: -0.05, 0.26) respectively.
- Similar Cardiovascular Safety in Hemodialysis Population : In the EMERALD studies, 22.8 percent of OMONTYS patients experienced one of the composite cardiovascular events, compared to 24.4 percent of epoetin patients (hazard ratio for the cardiovascular composite safety endpoint was 0.95 (0.77, 1.17) (95 percent CI)). OMONTYS is not indicated in patients with CKD not on dialysis. These patients experienced increased specific cardiovascular events.
In these studies, the most common adverse events (greater than ≥10%) were dyspnea, diarrhea, nausea, cough and arteriovenous fistula site complication.