New England Journal of Medicine Publishes Pivotal Trial Data for Omontys

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PALO ALTO, Calif. & DEERFIELD, Ill.—Affymax  and Takeda Pharmaceuticals U.S.A. announced that pivotal Phase 3 data on the safety and efficacy of Omontys were published in the January 24 issue of 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.

"The EMERALD results are important because they not only evaluated the efficacy of Omontys and epoetin; they also represent data from the first studies to prospectively compare the cardiovascular safety of different erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in dialysis patients with CKD," said Steven Fishbane, MD, Professor of Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, lead author of the NEJM publication, and principal investigator for the EMERALD studies. "The EMERALD data demonstrated that Omontys administered once a month has a similar efficacy and cardiovascular safety profile when compared to epoetin administered one-to-three times weekly."

About the EMERALD Studies and Cardiovascular Safety Assessment

Approximately 1,600 adult CKD hemodialysis patients across 178 sites in the U.S. and Europe were evaluated in the EMERALD 1 and 2 trials (1,066 patients received OMONTYS; 542 received epoetin). The primary efficacy endpoint of these studies was the mean change in Hb from the baseline Hb level to the mean level during the evaluation period (between weeks 29 through 36). In these trials, CKD patients on hemodialysis who were stable on epoetin, were randomized to receive OMONTYS either once every four weeks or to continue treatment with epoetin (according to epoetin labeling), with the dose adjusted as necessary to maintain Hb levels within the study-specified range (10.0-12.0 g/dL) for 52 weeks or more. Current Prescribing Information recommends reducing or interrupting the dose as Hb levels approach or exceed 11 g/dL.

The EMERALD studies were part of the first Phase 3 program to prospectively evaluate the CV safety of different ESAs based on a composite cardiovascular safety endpoint (CSE). The CSE was adjudicated by a blinded and independent committee. Events included in the CSE pre-specified analysis were death from any cause, stroke, myocardial infarction, serious adverse events associated with congestive heart failure, unstable angina, or arrhythmia.

About Anemia Due to CKD in Adult Patients on Dialysis

Anemia is a complication of CKD and is associated with cardiovascular illness and mortality. As of 2010, the United States Renal Data System noted there were more than 410,000 people in the United States who were on dialysis.

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