FDA Approved Drugs » 2012
Medical Areas: Hematology | Nephrology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved March 2012
Treatment Area: anemia due to chronic kidney disease
Omontys (peginesatide) is a peptide-based erythropoiesis stimulating agent (ESA). Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors.
Omontys is specifically indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.
Omontys is supplied as a solution for subcutaneous or intravenous injection. The recommended initial dose is 0.04 mg/kg body weight administered as a single intravenous or subcutaneous injection once monthly. In patients previously receiving epoetin alfa or darbepoetin alfa, the recommended starting monthly dose of Omontys should be estimated on the basis of the weekly dose of epoetin alfa or darbepoetin alfa at the time of substitution. See label for specific dosing levels.
FDA ApprovalThe FDA approval of Omontys was based on two randomized, active-controlled, open-label, multi-center clinical studies. The trials enrolled subjects who were being treated with another ESA (epoetin alfa or epoetin beta) at the time of study entry. The primary efficacy endpoint for each study was the change in hemoglobin from Baseline to the Evaluation Period (Weeks 29 to 36) using a non-inferiority comparison with epoetin.In Study 1, subjects received epoetin via the intravenous route of administration and continued to use this route after randomization to either Omontys or epoetin. In Study 2, the route of administration previously used for epoetin (intravenous or subcutaneous) was used. The subjects were randomized to receive Omontys once monthly, or to continue on their current ESA treatment 1 to 3 times per week. Non-inferiority was reached in both trials. A pooled analysis was also conducted evaluating a composite cardiovascular safety endpoint consisting of death, myocardial infarction, stroke, or serious adverse events of congestive heart failure, unstable angina or arrhythmia. In subjects receiving Omontys, 22.8% experienced one of these events compared to 24.4% receiving epoetin.
Adverse events associated with the use of Omontys may include, but are not limited to, the following:
Omontys (peginesatide) is a peptide-based erythropoiesis stimulating agent (ESA). It is comprised of two identical, 21-amino acid chains covalently bonded to a linker derived from iminodiacetic acid and ß-alanine. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in vitro.
For additional information regarding Omontys or anemia due to chronic kidney disease, please visit the Omontys web page.
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