-- Post-Hoc Data Provide Additional Information on Iron Utilization --
In these exploratory post-hoc analyses, investigators pooled data on IV iron dose, along with measures of iron deficiency -- serum ferritin and transferrin saturation (TSAT), from U.S. patients enrolled in the EMERALD 1 and 2 studies (approximately 80 percent of study population).
In the full analysis population (randomized patients receiving ≥1 study drug dose; n=853 OMONTYS, n=436 epoetin) over a 60-week period, patients in the OMONTYS group received an average of 148.8 mg of IV iron per month and patients in the epoetin group received 168.5 mg per month. In the completer population (≥60 weeks' drug exposure; ferritin, TSAT measured at same visit; n=604 OMONTYS; n=336 epoetin), patients in the OMONTYS group received an average of 152.9 mg per month and patients in the epoetin group received an average of 171.8 mg per month. TSAT at baseline was 30.2% and 29.4% in the OMONTYS and epoetin groups, respectively. Beginning at the first time point (week 12), TSAT for the full analysis population was 37.9% and 30.7% for OMONTYS and epoetin, respectively, and TSAT for the completer analysis population was 37.9% and 30.9% for OMONTYS and epoetin, respectively. Serum ferritin levels at baseline were 686 ng/mL and 674 ng/mL in the OMONTYS and epoetin groups, respectively. At week 60, serum ferritin levels for the full analysis population were 742 ng/mL and 768 ng/mL in the OMONTYS and epoetin groups, respectively, and serum ferritin levels for the completer analysis population were 733 ng/mL and 752 ng/mL in the OMONTYS and epoetin groups, respectively. The clinical significance of these analyses is unknown.
"Anemia management is multi-faceted and given the interdependence of irons and ESAs in red blood cell production, it's important to evaluate utilization of these agents in dialysis patients who are being treated for the condition," said
According to the OMONTYS prescribing information, healthcare professionals should correct or exclude other causes of anemia, including iron deficiency, before initiating treatment. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Evaluate transferrin saturation and serum ferritin prior to and during treatment, and administer supplemental iron when serum ferritin is less than 100 mcg/L or when serum ferritin saturation is less than 20%. For lack or loss of response to OMONTYS, initiate a search for causative factors, including iron deficiency. Please see full prescribing information, available at www.omontys.com.
About the EMERALD Studies
Evaluating approximately 1,600 dialysis patients across 172 sites in the U.S. and
The EMERALD studies were part of the first Phase 3 program to prospectively evaluate the cardiovascular (CV) safety of different ESAs based on a composite cardiovascular safety endpoint (CSE). The CSE was adjudicated by a blinded and independent committee.
About Anemia Due to CKD in Adult Patients on Dialysis
Anemia is a common complication in CKD patients on dialysis because their kidneys are unable to produce erythropoietin, the hormone responsible for red blood cell production. Since adequate iron levels are needed for the production of red blood cells and hemoglobin, treatment guidelines recommend iron is used in conjunction with erythropoiesis-stimulating agents (ESAs) in treating anemia in dialysis patients.
As of 2010, the United States Renal Data System noted there were 410,000 people in
OMONTYS® (peginesatide) Injection is a synthetic, pegylated, peptide-based ESA, and its building blocks (amino acids) are arranged in a different order than erythropoietin (i.e., it has no sequence homology to endogenous erythropoietin).
Indication and Limitations of Use
OMONTYS® (peginesatide) Injection is indicated for the treatment of anemia due to chronic kidney disease (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.
IMPORTANT SAFETY INFORMATION
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE.
Chronic Kidney Disease:
OMONTYS is contraindicated in patients with uncontrolled hypertension.
Warnings and Precautions
Increased mortality, myocardial infarction, stroke, and thromboembolism:
Hypertension (see Contraindications): Appropriately control hypertension prior to initiation of and during treatment with OMONTYS. Reduce or withhold OMONTYS if blood pressure becomes difficult to control.
Lack or loss of response to OMONTYS: Initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for antibodies to peginesatide.
Dialysis management: Patients receiving OMONTYS may require adjustments to dialysis prescriptions and/or increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.
Laboratory monitoring: Evaluate transferrin saturation and serum ferritin prior to and during OMONTYS treatment. Administer supplemental iron therapy when serum ferritin is less than 100mcg/L or when serum transferrin saturation is less than 20%. Monitor hemoglobin every 2 weeks until stable and the need for RBC transfusions is minimized. Then, monitor monthly.
Most common adverse reactions in clinical studies in patients with CKD on dialysis treated with OMONTYS were dyspnea, diarrhea, nausea, cough, and arteriovenous fistula site complication.
The company's first marketed product, OMONTYS, was approved by the
Affymax Forward-Looking Statement
This release contains forward-looking statements, including statements regarding the potential of OMONTYS, the continuation and success of Affymax's collaboration with Takeda and the commercialization of OMONTYS.
About Takeda Pharmaceuticals
Takeda Forward-Looking Statement
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