REDWOOD CITY, Calif., April 21, 2016 (GLOBE NEWSWIRE) — Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that new analyses from studies of Veltassa® (patiromer) for oral suspension will be presented at the National Kidney Foundation (NKF) 2016 Spring Clinical Meetings, taking place April 27-May 1 in Boston.
Veltassa was approved by the U.S. Food and Drug Administration for the treatment of hyperkalemia in the United States on October 21, 2015, becoming the first medicine in more than 50 years for people with elevated serum potassium.
Data to be presented include:
- Results from a proof of concept study (RLY5016-201) that evaluated the effect of Veltassa on potassium and phosphate in six hyperkalemia patients on hemodialysis;
- An analysis evaluating the effect of Veltassa on urine calcium and phosphate excretion from the Phase 1 RLY5016-101 and 102 studies in healthy adults;
- Data from a post-hoc sub-group analysis of patients with resistant hypertension in the Phase 2 AMETHYST-DN trial, which evaluated Veltassa over 52 weeks in hyperkalemia patients with chronic kidney disease (CKD) and type 2 diabetes who were taking renin angiotensin aldosterone system (RAAS) inhibitors.
Additionally, an epidemiologic research poster presentation will highlight results of a longitudinal study that evaluated racial differences in the prevalence, patterns and mortality associated with hyperkalemia among U.S. veterans.
Presenters will be available for questions at posters on Thursday, April 28, from 6:00-7:30 p.m. ET. Posters will be available for viewing over the course of the conference.
Veltassa Poster Presentations
| Abstract Title: | Patiromer decreases serum potassium and phosphate in patients on hemodialysis |
| Presenter: | David A. Bushinsky, M.D., John J. Kuiper Distinguished Professor of Medicine and of Pharmacology and Physiology at the University of Rochester School of Medicine, and Chief of the Nephrology Division at the University of Rochester Medical Center |
| Poster Number: | 310 |
| Abstract Title: | Effect of patiromer on urine calcium and phosphate excretion in healthy adults |
| Presenter: | David A. Bushinsky, M.D., John J. Kuiper Distinguished Professor of Medicine and of Pharmacology and Physiology at the University of Rochester School of Medicine, and Chief of the Nephrology Division at the University of Rochester Medical Center |
| Poster Number: | 309 |
| Abstract Title: | Strategy for improved blood pressure (BP) control in resistant hypertension (RH) with diabetic kidney disease (DKD) |
| Presenter: | Murray Epstein, M.D., Professor of Medicine, Leonard M. Miller School of Medicine, University of Miami |
| Poster Number: | 313 |
Hyperkalemia Poster Presentation
| Abstract Title: |
Racial differences in the prevalence, patterns and mortality associated with hyperkalemia among 3 million veterans |
| Presenter: | Morgan Grams, M.D., Ph.D., Associate Professor, School of Medicine, Johns Hopkins Bloomberg School of Public Health |
| Poster Number: |
314 |
About Hyperkalemia
Approximately 3 million people in the United States with stage 3 or 4 CKD and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are frequently prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include RAAS inhibitors, such as ARBs (angiotensin receptor blockers), AAs (aldosterone antagonists) and ACE (angiotensin-converting-enzyme) inhibitors.
About Veltassa
Veltassa is a potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water (90 milliliters or 3 ounces) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.
IMPORTANT SAFETY INFORMATION
The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. Other oral medications should be administered at least 6 hours before or 6 hours after Veltassa. Doctors should choose Veltassa or the other oral medication if adequate dosing separation is not possible.
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components. The Prescribing Information for Veltassa includes Warnings and Precautions for worsening of gastrointestinal motility and hypomagnesemia. The most common adverse reactions (incidence ≥2 percent) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.
For additional Important Safety Information and Veltassa’s full Prescribing Information, please visit www.relypsa.com/veltassa/prescribing-information.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company’s first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa’s rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.
Contact:
Alex Dobbin
Associate Director, Investor Relations
650.421.9687
IR@relypsa.com
