- In the study, Veltassa, the first new medicine approved by the FDA for hyperkalemia in more than 50 years, showed a consistent potassium-lowering effect and safety profile whether taken with or without food
- Hyperkalemia, or elevated blood potassium levels, affects 3 million people in the U.S. with stage 3 or 4 chronic kidney disease and/or heart failure; if untreated, it can cause abnormal heart rhythms and even sudden death
- Relypsa plans to submit a supplemental New Drug Application to the FDA to revise the Veltassa label to reflect the data
REDWOOD CITY, Calif., April 19, 2017 (GLOBE NEWSWIRE) -- Relypsa, Inc., a Vifor Pharma Group company, today announced that data from its Phase 4 TOURMALINE study of the effect of Veltassa® (patiromer) for oral suspension on hyperkalemia when taken with or without food were presented in a poster session at the National Kidney Foundation (NKF) 2017 Spring Clinical Meetings in Orlando, Fla. Topline results from the TOURMALINE study were previously announced in August 2016.
“TOURMALINE is the first study to evaluate the efficacy and safety of Veltassa taken with or without food,” said Pablo Pergola, M.D., Ph.D., primary investigator of the TOURMALINE study, research director of Renal Associates, P.A., and clinical associate professor of medicine at the University of Texas Health Science Center at San Antonio. “The results presented today are important because they demonstrate that Veltassa has a consistent potassium-lowering effect and safety profile whether taken with or without food. For patients with hyperkalemia, the ability to take Veltassa without food could provide greater flexibility in incorporating the medicine in their daily treatment regimen.”
The results presented today at the NKF meeting by Dr. Pergola showed no statistically significant difference in the percentage of patients achieving serum potassium levels within the target range (3.8 to 5.0 mEq/L) between the groups taking Veltassa with or without food at either week 3 or week 4 follow-up (p=0.7893). Among study participants taking Veltassa with food, 87.3 percent achieved and maintained a potassium level in the target range as did 82.5 percent of those taking Veltassa without food. Results were consistent when evaluated by baseline potassium, race, eGFR (an assessment of kidney function) and type 2 diabetes. Patients with higher baseline potassium values generally had greater potassium reductions. Rates of adverse events were consistent with previous clinical trials of Veltassa and were similar between study participants who took Veltassa with food (48.2 percent) and those who took it without food (42.1 percent).
“Current prescribing information requires that Veltassa be taken with food. That is how the drug was administered in the original clinical studies supporting U.S. Food and Drug Administration approval,” said Alain Romero, Ph.D., Pharm.D., vice president, Medical and Scientific Affairs, at Relypsa. “As the TOURMALINE study showed consistent efficacy and safety with Veltassa when taken with or without food in patients with hyperkalemia, we are preparing a supplemental New Drug Application based on these findings. We look forward to working with the FDA to revise the U.S. Veltassa label to reflect this important information.”
TOURMALINE Study Design
The TOURMALINE study randomly assigned 114 patients with blood potassium levels greater than 5.0 mEq/L to receive Veltassa once-a-day at a starting dose of 8.4 g either with or without food. Patients were treated for four weeks and followed for two weeks after completing Veltassa treatment. The primary endpoint was a comparison of the proportion of patients with blood potassium in the target range (3.8 to 5.0 mEq/L) at week 3 or week 4 between the two treatment groups. Of the 112 evaluable patients, 65 percent were male, 65 percent were age 65 or older, and 62 percent had stage 3b-5 chronic kidney disease.
About Hyperkalemia
Approximately 3 million people in the United States with stage 3 or 4 chronic kidney disease (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 often 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 renin angiotensin aldosterone system (RAAS) inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors.
About Veltassa
Veltassa is a sodium-free 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 (one-third of a cup) 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
Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.
Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.
Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.
Adverse Reactions
The most common adverse reactions (incidence ≥2 percent) are 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 Veltassa’s full Prescribing Information, please visit https://www.veltassa.com/pi.pdf.
About Relypsa, Inc.
Relypsa, Inc., a Vifor Pharma Group company, 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. More information is available at www.relypsa.com.
About Vifor Pharma Group
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for specialty pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. The Vifor Pharma Group, headquartered in Zurich, Switzerland, holds a leading position in all its core business activities. Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, security number CH036 067 446 6). For more information, visit www.viforpharma.com.