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PALO ALTO, Calif., Aug 11, 2011 (BUSINESS WIRE) -- Affymax, Inc. today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012 for the review of the investigational agent peginesatide (formerly known as Hematide(TM)) New Drug Application (NDA). The company had announced on July 27, 2011 that the FDA accepted the peginesatide NDA submission for review.
If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent (ESA) available for the treatment of anemia associated with CKD patients on dialysis in the United States.
Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA. The NDA included data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels) in maintaining hemoglobin (Hb) levels. In the studies, over 1,600 CKD patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was comparable to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia with a similar adverse event rate. The most common adverse events reported in the clinical studies were diarrhea, cough, dyspnea, nausea, and muscle spasm. A similar frequency of serious adverse events was reported between the EMERALD treatment groups.
"To date, limited options exist for treating anemia in chronic kidney disease patients on dialysis," said John Orwin, chief executive officer of Affymax. "The peginesatide New Drug Application represents an important step in the evaluation of this potential new treatment for the many dialysis patients impacted by this common condition."
About Peginesatide
Affymax and Takeda Pharmaceutical North America are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States. The product, upon approval, will be commercialized outside the United States by Takeda. The peginesatide Phase 3 clinical program was the largest to support the registration of an ESA for the treatment of anemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events.
About Anemia in Chronic Kidney Disease
Anemia is a common complication in CKD, because the impaired kidneys are not able to produce enough erythropoietin, the hormone that promotes the production of oxygen-carrying red blood cells. Research has shown that anemia impacts the overall health and well being of CKD and dialysis patients and is associated with increased rates of hospitalization and mortality. In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs.
ESAs, which stimulate red blood cell production, are commonly prescribed to treat anemia of CKD. According to the Centers for Medicare and Medicaid Services, more than 95 percent of patients on dialysis in the U.S. are currently receiving ESA treatment for anemia of CKD.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com .
This release contains forward-looking statements, including statements regarding the continuation and success of Affymax's collaboration with Takeda, milestones expected to be accomplished, timing, design and progress of the peginesatide development program and the timing and potential regulatory approval and commercialization of peginesatide. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the approvability and completeness of the New Drug Application (NDA) filing, risks relating to regulatory requirements and approvals, in particular the FDA's interpretation and review of the data in the NDA including issues related to the subgroup analyses in non-dialysis, data quality and integrity particularly in non-inferiority designed trials, the continued safety and efficacy of peginesatide in clinical development, the timing of patient accrual in ongoing and planned clinical studies, research and development efforts, industry and competitive environment, intellectual property rights and disputes and potential for costs, disruptions and consequences of litigation, financing requirements and ability to access capital and other matters that are described in Affymax's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Affymax undertakes no obligation to update any forward-looking statement in this press release.
SOURCE: Affymax, Inc.
Author Interviews: hemodialysis
- Dialysis - ESRD - CKD |
| Characterizing Missed Dialysis Sessions in the ESRD Patient population |
| Hemoglobin Recovery following Hospitalization in ESRD patients |
| Association of Serum Sodium Levels with Mortality in Non-Dialysis Dependent Chronic Kidney Disease |
| Talking Control Support in Hemodialysis Results in Higher Patient Satisfaction Survey Response |
| Use of Fondparinux in Severe Renal Impairment & Hemodialysis |
| Contribution of CA, phosphorus & 25-VitD to the excessive severity of sPTH in African-Americans with CKD |
| Comparison of Risk Prediction Using the CKD-EPI Equation & the MDRD Study Equation for eGFR |
| Iron-Based Phosphate Binder PA21: Effective and Well Tolerated in CKD Hemodialysis Patients |
| Hemoglobin Recovery following Hospitalization in ESRD patients |
| Disease Management Program ESRD Patients Have Lower Overall Medical Costs |
Crit-Line Monitor Use in Incident Hemodialysis Patients Improves Dry Weight and Adequacy,
While Reducing Epoetin Alfa Dose: A Propensity Score Matched Study |
| Perceptions & Roles of Nephrology Social Worker Within the Suicide Continuum of Care |
| Reduced Use of ESAs and IV Iron with Ferric Citrate: A Medicare Bundle Cost-Offset Model |
| Video Education Increases Patient Knowledge About Phosphorus Control |
| Effect of a plasma sodium biofeedback system applied to HFR on the intradialytic cardiovascular stability |
| Hemodialysis Access and Age-related Postoperative Outcomes: Which Fistula First? |
| Coronary Artery Calcification & Pre-Hemodialysis Bicarbonate Levels in Hemodialysis |
| Protein/omega-3 supplementation during regular dialysis sessions & inflammatory indices in hemodialysis |
| VDRA and improved survival in dialysis patients with serum intact PTH ≤150 pg/mL |
| Relation of social support to mental health and locus of control in Chronic Kidney Disease |
| Depression and anxiety in patients with chronic renal failure |
| Self -esteem in Greek dialysis patients: The contribution of health locus of control |
| Medication adherence in Greek hemodialysis patients: Contribution of depression and health cognition. |
| Association of insomnia with kidney disease quality of life reported by patients on maintenance dialysis |
| Comorbidities/ inactivity & long-term outcomes of CABG in small number of men on chronic hemodialysis |
| Complete Recovery From Acute Kidney Injury With Incident CKD Stage 3 and All-Cause Mortalit |
| Outcomes of patients with ESRD under chronic hemodialysis requiring CRRT & in AKI requiring CRRT |
| Radiologically Placed Tunneled Hemodialysis Catheters: Pediatric Institutional Experience of 120 Patients |
| Preload dependence of gated cardiac SPECT-derived ventricular volumes in hemodialysis |
| Effect of Hemoglobin Target on Progression of Kidney Disease |
| eGFR at Reinitiation of Dialysis & Mortality in Failed Kidney Tranplant Recipients |
| Biomarkers Determining Cardiovascular Risk in Kidney Disease |
| Rural and Micropolitan Residence & Mortality in Dialysis |
| Urinalysis is more specific & urinary NGAL is more sensitive for early AKI detection |
| Vascular Klotho Deficiency Potentiates Development of Arterial Calcification & Mediates FGF23 Resistance |
| Efficacy of preventing hemodialysis catheter infections with citrate lock: Hemodialysis Int'l |
| Learn about dialysis options from a Home Dialysis Therapy Nurse |
| Optimal fluid control can normalize CV risk markers and limit LV hypertrophy in thrice weekly dialysis |
| LDL, atherosclerosis and mortality in hemodialysis |
| Pulmonary hypertension in chronic kidney disease on dialysis/ without dialysis |
| Predictors of steal syndrome in hemodialysis Hemodialysis Int'l |
| Sodium intake and blood pressure in renal transplant recipients Nephrology Dialysis Transplant |
| HIV-associated nephropathy patients with & without apolipoprotein L1 gene variants Kidney International |
| Depression and nonadherence predict mortality in hemodialysis treated ESRD patients Hemodialysis Int'l |
| Serum Metabolite Concentrations and Decreased GFR in the General Population AJKD |
| High Volume Peritoneal Dialysis in Acute Kidney Injury CJASN |
| Trial of Catheters of Different Lengths to Achieve Right Atrium vs SVC Placement for CRRT AJKidneyDs |
Pre-kidney transplant ESA agence responsiveness with post-transplant outcomes
Nephrology Dialysis Transplant |
| Prognostic Value of 48-Hour Ambulatory BP & CV Mortality in Hemodialysis Kidney Blood Press Res |
| Darbepoetin-α Cardiovascular Geometry and CKD -Cardiorenal Med |
| Influenza Vaccine Effectiveness in Patients on Hemodialysis Arch Intern Med |
| Bioelectrical Impedance Analysis & Skinfold Thickness Sum in Body Fat Mass in Dialysis J.Renal Nutrition |
| Pre-Diabetes after Renal Transplantation Nephrology Dialysis Transplant |
| Essential trace element status and clinical outcomes in long-term dialysis |
| End-of-Life Decision-Making Confidence in Surrogates of AA Dialysis Patients Is Overly Optimistic |
| Comparison of Cardiac PET Perfusion Defects During Stress Induced by Hemodialysis vs Adenosine AJKD |
| Mental Health over Time & Cardiac Outcomes in HEMO Study CJASN |
| Cholesterol Synthesis, Cholesterol Absorption, & Mortality in Hemodialysis CJASN |
| Statins, Risk & Outcome in Acute Kidney Injury in Community-Acquired Pneumonia CJASN |
| Dialysis-Dependent Changes in Ventricular Repolarization |
| High Burden of Kidney Disease in Youth-Onset Type 2 Diabetes Diabetes Care |
| Late Start Dialysis & Outcomes in Japanese Dialysis: Therapeutic Apheresis & Dialysis |
| Pica in Pediatric Dialysis - J.Renal Nutrition |
| Elemental Concentrations in Scalp Hair in Hemodialysis Patients Therapeutic Apheresis & Dialysis |
Health-related QOL was not improved by targeting higher hemoglobin in the Normal Hematocrit Trial
Kidney Int'l |
| Sevelamer on HbA1c, Inflammation, & Advanced Glycation End Products in Diabetic Kidney Disease CJASN |
| Increasing organ donation via anticipated regret proposed protocol |
| Statins on Chronic Inflammation and Nutrition status in Renal Dialysis |
| Emergency Department Use of Urinary Biomarkers of Nephron Damage |
| Preemptive renal transplant survival, access to care, & renal function at listing Nephrology Dialysis Transplant |
| Effect of Diuretic Use on 30-Day Postdialysis Mortality in Critically Ill Patients Receiving Acute Dialysis Dr. Ko |
| FGF23 predicts incident cardiovascular event before but not after the start of dialysis Dr. Isaka |
| Mortality Prediction by Surrogates of Body Composition: An Examination of the Obesity Paradox in Hemodialysis Using Composite Ranking Score Analysis: Drs. Miklos Z Molnar & Kamyar Kalantar-Zadeh |
| Plasma Sodium & Blood Pressure in Hemodialysis J.Human Hypertension |
| Increased Risk of Death in Young African American Dialysis Patient: Dr. Norman |
| Nutritional Management of Stage 5 CKD J. Renal Nutrition |
A proposed management algorithm for fistulae between hemodialysis access circuits and adjacent veins
Vasc Access |
| Percutaneous approach in maintenance & salvage of dysfunctional autologous vascular access for dialysis |
| The Kidney Disease Quality of Life Cognitive Function Subscale and Cognitive Performance in Maintenance Hemodialysis Patients Amer. J Kidney Diseases |
| Absolute Interdialytic Weight Gain is more important than Percent Weight Gain for Intradialytic Hypotension in heavy hemodialysis patients: Dr. Chen Nephrology |
| Postdialysis BP rise predicts outcomes in hemodialysis: Dr Yang BMC Nephrology |
| APOL1 allelic variants are associated with lower age of dialysis initiation Nephrology Dialysis Transplant |
| Effects of Six versus Three Times per Week Hemodialysis on Physical Performance, Health, and Functioning: Frequent Hemodialysis Network (FHN) Randomized Trials Dr. Hall CJASN |
| Variability of blood pressure in dialysis patients: a new marker of cardiovascular risk Dr. Di Iorio |
| Assessment of Body Composition Using Dry Mass Index and Ratio of Total Body Water to Estimated Volume Based on Bioelectrical Impedance Analysis in CKD J. Renal Nutrition |
| Potential Role of Active Vitamin D Treatment in Telomere Length in Hemodialysis: Dr Valdivielso |
| CKD, severe arterial & arteriolar sclerosis & kidney neoplasia MELAS syndrome Dr. Piccoli BMC Nephrology |
| Pedometer-Assessed Physical Activity in Children and Young Adults with CKD |
| Effect of Frequent or Extended Hemodialysis on Cardiovascular Parameters Amer J. Kidney Ds |
| Exposure to bisphenol A is associated with low-grade albuminuria in Chinese adults Dr. Guang Kidney Int'l |
| Increased dietary sodium and greater mortality in hemodialysis Kidney Int'l |
| Sonography Characteristics of the Intra-Dialysis-Graft Thrombus Dr. Cheng |
Featured Hemodialysis Interviews |
Home Dialysis Summit Recommends Policy Changes to Increase Home Dialysis Usage
WASHINGTON, April 25, 2012 /PRNewswire -- On the heels of the first National Summit on Home Dialysis Policy, Summit organizers released a report reflecting the views of the delegates -- leaders in the kidney disease patient, clinician, facility and industry communities -- on federal policy steps to improve utilization of home dialysis for patients who can benefit from this often advantageous form of treatment. Many of the organizers also announced they have formed a new alliance, called the Alliance for Home Dialysis, to advance the recommendations identified at the Summit.
The Summit's "Report of the Delegates" highlights key findings from a March 29th meeting in Washington, DC where experts probed why, despite widely accepted and well-documented benefits of home dialysis -- improved outcomes, enhanced patient satisfaction, improved quality of life, and lower costs-- fewer than ten percent of the more than 390,000 current U.S. dialysis patients receive treatment at home. Current rates of home dialysis utilization reflect a steep decline from the 1970s, when almost 40% of U.S. dialysis patients were treated in-home.
Specifically, delegates found that policymakers should work with stakeholders in the dialysis community to confront three areas:
Accessibility: Patients and clinicians face array of hurdles in education, training, and infrastructure that hinder equalized access to home dialysis.
Accountability: Utilization of home dialysis can be improved through measures within government programs that are designed to recognize and support excellence in the delivery of home dialysis services.
Aligning Incentives: Reimbursement policies, regulation of new technologies and other policy incentives can be realigned to better support federal policy goals of expanding access to home dialysis.
The Report includes 15 recommendations to serve these goals, including that federal policymakers should:
Maintain parity for home and in-center dialysis in Medicare reimbursement;
Support home dialysis mentoring programs, particularly those that use existing patients as mentors; and
Align federal and state regulatory requirements for home therapies, such as revising the Centers for Medicare and Medicaid Services Conditions for Coverage requirements, to reflect differences in home and in-center dialysis.
Summit supporters will begin work through the new Alliance to dialogue with federal policymakers and advance policy improvements in the three consensus areas that emerged at the Summit.
SOURCE National Summit on Home Dialysis Policy
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National Kidney Foundation's Top 10 Things Every Dialysis Patient Should Know.
- You have treatment choices. Options exist for how, where and when you dialyze. Dialysis can be done in a hospital, in a dialysis unit that is not part of a hospital, or at home. You and your doctor will decide which place is best, based on your medical condition and your wishes. There are different types of dialysis - peritoneal and hemodialysis. Work with your health care team to determine a treatment plan that makes you feel comfortable. Recent studies show that the majority of patients beginning in-center hemodialysis (HD) know very little, if anything, about the option to dialyze at home. Once informed, 40% or more of patients are interested in this treatment option, and yet less than 10% actually begin home dialysis. If you're dissatisfied with the type of dialysis treatment that you're receiving, ask your healthcare team if another type of dialysis treatment would be better.
- You can compare in-center dialysis facilities online. Information on over 5,600 US-based dialysis centers is available online through the Medicare website. To help you make choices about your care, you can compare different facilities side-by-side and evaluate each facility based upon clinic characteristics and quality measures. You can search for dialysis facilities by name or geographic proximity. After completing an initial facility comparison to determine which facilities best meet your needs - such as the number of hemodialysis stations at a particular location and whether there are evening shifts available - visit the facilities that you're most interested in. Talk to the staff and other patients, as well as your doctor to ensure that this dialysis facility is a good fit for you.
- There are ways to prepare ahead for an emergency. Ask your dialysis facility about their emergency plan in case of a snow storm, fire, power outage or other natural disaster. As back up, make sure you have the names, locations and phone numbers of other dialysis units and hospitals in your area. Since regular community transportation services may not be working in an emergency, be prepared to make other arrangements for getting to dialysis. You may need to contact the police and Emergency Medical Services (EMS) for assistance. If you dialyze at home, make sure you have at least two weeks' worth of unexpired supplies on hand. If you have to miss a dialysis treatment, begin your emergency meal plan.
- There is an easy way to transfer patient records between clinics. There is an easy, secure way for your health care team to transfer your treatment records online. In 2009, the Centers for Medicare and Medicaid Services (CMS) created a centralized web-based data collection system called CROWNWeb to help reduce and eliminate patient treatment interruptions. This central system helps to streamline patient care regardless of the reason for changing dialysis centers. For example, if you've been admitted to the hospital, or if you needed to relocate during an emergency evacuation, your doctors and health care team can access up-to-date information about your dialysis so that you continue to receive appropriate care no matter where you are.
- You can travel while on dialysis.
Dialysis centers are located in every part of the United States and in many foreign countries. The treatment is standardized, but you need to plan ahead by making an appointment for dialysis at another center before you go. The staff at your center may help you make these appointments.
- You can be your own best advocate. Know what key questions to ask your doctor or other healthcare professionals. Take notes so that you can refer back to them later. Partner with your doctor and decide on a treatment plan together. Advocate for yourself and share how you're feeling.
- You have many rights. You as a patient have a great deal of control over your treatments. Patients have a bill of rights which includes receiving quality care, counseling about your medical information, and an expectation of privacy.
You also have responsibilities. Once you decide on a course of treatment, it's important to follow the recommendations of your health care team. If you decide to receive in-center dialysis, arrive at dialysis on time so that you can receive the full treatment without delays.
- You can receive insurance coverage. If you have end stage renal failure, you are likely eligible for Medicare insurance coverage. Speak with your health care team and social worker for help filling out insurance paperwork.
- You may need to follow a special diet. When your kidneys are not working properly, you may not be able to eat everything you like, and you may need to limit how much you drink. Your diet may vary according to the type of dialysis you receive. It is important to speak with a renal dietitian so that you are able to understand what you can and cannot eat based on your full health history.
- Dialysis patients can work. Many dialysis patients can go back to work or school after they have gotten used to dialysis. After establishing a dialysis routine, many patients have more energy and find that they are able to time to work around this new schedule. Some patients even find creative ways to work remotely from dialysis with the use of a laptop or cell phone, depending on their field of expertise.
More from National Kidney Foundation Press Releases
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New Book to Help Educate Patients with Chronic Kidney Disease who may be facing Dialysis or Hemodialysis: |
Help, I Need Dialysis!
How to have a good future with kidney disease
By Dori Schatell, MS and Dr. John Agar
An internationally known nephrologist and life-long kidney patient educator explain how dialysis works, each of the ways to do it, and how your treatment choice may affect your diet, energy level, work, travel, sexuality and fertility, sleep, and survival. Comprehensive and fully referenced, this book is a must-read if you face the life-changing choices that come with kidney failure. |
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