FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions
REDWOOD CITY, Calif., November 27, 2016 – Relypsa, Inc., a Vifor Pharma company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) with important updates to the label of Veltassa (patiromer) for oral suspension. Veltassa’s label no longer includes a Boxed Warning regarding the separation of Veltassa and other oral medications. The updated label recommends patients take Veltassa at least 3 hours before or 3 hours after other oral medications. This information is now detailed in the dosage and administration section (Section 2) and the drug interactions section (Section 7) of the label. In addition, data from the Veltassa drug-drug interaction program has been added to the Clinical Pharmacology section of the label (Section 12).
“We are extremely pleased the FDA has approved these changes to Veltassa’s label, including removal of the Boxed Warning. These important updates are based on our positive data, which showed there is a low risk for drug-drug interactions with Veltassa when it is separated from other oral medications by at least 3 hours,” said John A. Orwin, president and chief executive officer of Relypsa. “We believe the 3-hour dose separation and addition of data from our drug-drug interaction program to the label can provide doctors greater flexibility in choosing Veltassa and adding it to patients’ daily treatment regimen.”
About the Veltassa Drug-Drug Interaction Program
Veltassa was approved by the FDA 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 blood potassium levels.
The drug-drug interaction program tested 28 drugs to determine the potential for interaction with Veltassa. Fourteen drugs showed no interaction with Veltassa in in vitro drug-drug interaction tests (conducted in test tubes). Of the 14 drugs that did show an interaction in vitro, 12 were selected for further testing in Phase 1 studies in healthy volunteers to assess whether the results seen in vitro translated into an effect in people. These studies showed Veltassa did not alter the absorption of nine of the 12 drugs when co-administered. Veltassa reduced absorption of three drugs when co-administered, however, there was no interaction when Veltassa and these three drugs were taken 3 hours apart.
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 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
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.
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. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company. More information is available at www.relypsa.com.
About Vifor Pharma
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world. For more information about Vifor Pharma, please visit www.viforpharma.com.
Source: Relypsa, Inc.
Posted: November 2016
- FDA Approves Veltassa (patiromer) for Hyperkalemia - October 21, 2015
- Relypsa Announces October 21, 2015 as PDUFA Date for NDA for Patiromer for Oral Suspension - January 5, 2015
- Relypsa Announces FDA Acceptance of New Drug Application for Patiromer for Oral Suspension to Treat Hyperkalemia - December 15, 2014
- Relypsa Submits NDA for Patiromer for Oral Suspension to Treat Hyperkalemia - October 22, 2014