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US FDA approves removal of boxed warning on Relypsa's hyperkalemia drug, Veltassa

Redwood City, California
Wednesday, November 30, 2016, 17:00 Hrs  [IST]

Relypsa, Inc., a Vifor Pharma company, announced that the US 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.”

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.


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