Updated label may allow for increased dosing flexibility for patients with hyperkalemia (elevated blood potassium) – a chronic, asymptomatic condition that often coexists with other disorders, including chronic kidney disease, heart failure, diabetes and/or high blood pressure
REDWOOD CITY, Calif., May 08, 2018 (GLOBE NEWSWIRE) -- Relypsa, Inc., a Vifor Pharma Group company, today announced that the United States (U.S) Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for Veltassa® (patiromer) for oral suspension in the treatment of hyperkalemia, or elevated blood potassium levels. The label update is effective immediately and based on results from the Phase 4 TOURMALINE study, which showed no statistically significant difference between the groups taking Veltassa with or without food in achieving serum potassium levels within the target range (3.8 to 5.0 mEq/L).
“Since the U.S. approval of Veltassa two years ago, we have seen how the availability of this medicine has been able to significantly transform the way physicians treat hyperkalemia,” said Scott Garland, president of Relypsa. “We are pleased with the FDA's approval of this supplement and believe the updated label will provide patients with greater flexibility in incorporating Veltassa in their daily treatment regimen.”
In the TOURMALINE study, 87.3 percent of the Veltassa with food group and 82.5 percent of the Veltassa without food group achieved potassium levels in the target range at either week 3 or week 4. Patients with higher baseline potassium values generally had greater potassium reductions. Results were consistent when evaluated by baseline potassium, race, eGFR (an assessment of kidney function) and type 2 diabetes. 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).
TOURMALINE Study Design
The 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. The study was conducted at 29 sites in the United States. Of the 112 patients evaluable for efficacy, 65 percent were male, 12.5 percent were African American, 56 percent were Hispanic/Latino, 65 percent were age 65 or older and 62 percent had stage 3b-5 (non-dialysis) chronic kidney disease.
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.
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. 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
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.
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.
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 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 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. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa; and OM Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.
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