Only Once-Monthly ESA Treatment For Dialysis Patients To Be Made
The FDA's decision was based on a New Drug Application (NDA), which included results from two randomized, controlled, open-label, Phase 3 studies (EMERALD 1 and 2) that demonstrated the safety and efficacy of OMONTYS dosed once monthly, compared to epoetin dosed between one-to-three times per week (according to product labels), in maintaining hemoglobin (Hb) levels in anemic CKD patients on dialysis. In these studies, the most commonly reported adverse reactions were shortness of breath, diarrhea, nausea, cough and arteriovenous fistula site complication. The EMERALD studies were part of the largest clinical program to support the NDA of an ESA in the treatment of anemia in CKD. Enrolling 2,606 patients, including approximately 1,600 dialysis patients, the OMONTYS Phase 3 program was also the first to prospectively compare, in a head-to-head manner, the cardiovascular safety of different ESAs. Cardiovascular safety was evaluated based on a composite cardiovascular safety endpoint adjudicated by a blinded and independent committee. See below for Important Safety Information about OMONTYS, including Boxed Warnings as well as limitations of use.
In the approval action letter, the
"The approval of OMONTYS now provides a therapeutic alternative to treat
anemia of CKD in adult patients on dialysis, one of the most common
complications affecting this patient population," said
"The FDA's approval of OMONTYS signifies an important milestone for the
partnership between Takeda and
Anemia (a condition in which blood has a lower than normal number of red
blood cells) is a common complication in dialysis patients because their
kidneys no longer produce enough erythropoietin, the hormone that
stimulates red blood cell production in the body. According to the
"For dialysis patients, anemia is another aspect of their challenging
condition that must be addressed," said
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OMONTYS® (peginesatide) Injection is a synthetic, pegylated,
peptide-based ESA. It is the only ESA that is peptide-based and its
building blocks (amino acids) are arranged in a different order than
erythropoietin (i.e., it has no sequence homology to endogenous
erythropoietin). OMONTYS was discovered by
The objective of the OMONTYS Phase 3 dialysis studies (EMERALD 1 and 2) was to evaluate the safety and efficacy of OMONTYS, dosed once monthly, compared to epoetin alfa or beta, dosed one-to-three times per week (according to the product labels), in maintaining Hb levels. The primary efficacy endpoint of these two studies was a mean change in Hb between baseline and evaluation period (between weeks 29 through 36) following entry into the study.
In the EMERALD studies, CKD patients on dialysis who were stable on epoetin were randomized to receive OMONTYS either once monthly or to continue treatment with epoetin.
For more information about OMONTYS, visit www.omontys.com.
About Anemia Due to CKD in Adult Patients on Dialysis
Anemia is a complication of CKD that is associated with cardiovascular
illness and mortality. As of 2009, the United States Renal Data System
noted there were nearly 400,000 people in
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:
Increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer: The safety and efficacy of OMONTYS have not been established for use in patients with anemia due to cancer chemotherapy. OMONTYS is not indicated in patients with cancer receiving chemotherapy.
Hypertension: OMONTYS is contraindicated in patients with uncontrolled hypertension. Appropriately control hypertension prior to initiation of and during treatment with OMONTYS. Reduce or withhold OMONTYS if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.
Lack or loss of response to OMONTYS: For lack or loss of hemoglobin 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 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 100 mcg/L or when serum transferrin saturation is less than 20%.
The 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.
This release contains forward-looking statements, including
statements regarding the potential advantages of OMONTYS, the
continuation and success of
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Vice President, Corporate Communications
Takeda Pharmaceutical Company Limited
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