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Relypsa (RLYP) Announces European Approval Of Veltassa To Treat Adult Patients With Hyperkalemia (Elevated Blood Potassium Levels)



7/21/2017 8:28:53 AM

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  • Today’s European Commission approval is the second worldwide; in the U.S., more than 33,000 patients have been treated with Veltassa since it was approved by the FDA in 2015
  • Patients with advanced chronic kidney disease (CKD) and/or heart failure are especially susceptible to hyperkalemia, which, if untreated, can lead to abnormal heart rhythms and even sudden death
  • The first launches of Veltassa in Europe are anticipated by year-end 2017 or early 2018

REDWOOD CITY, Calif., July 21, 2017 (GLOBE NEWSWIRE) -- Relypsa, Inc., a Vifor Pharma Group company, today announced that the European Commission (EC) has approved the Marketing Authorization Application (MAA) for Veltassa® (patiromer) for the treatment of hyperkalemia, or elevated blood potassium levels. Veltassa, which is the brand name for patiromer in both the U.S. and Europe, is approved for marketing in all 28 EU countries and in Iceland, Liechtenstein and Norway. Vifor Pharma Group plans to launch Veltassa in Europe by the end of 2017 or in early 2018.

“The European approval of Veltassa marks the first regulatory approval for this important medicine outside the U.S., further validating our innovative polymer science,” said Scott Garland, president of Relypsa. “In the U.S., we are encouraged by the growing acceptance and uptake of Veltassa by clinicians and patients. In the 18 months since we launched Veltassa, more than 33,000 patients with hyperkalemia, a serious and often chronic health concern, have been treated with it. We look forward to working with our colleagues at Vifor Pharma Group to help bring Veltassa to patients in Europe, where a new daily treatment for hyperkalemia is needed.”

In the EU, Veltassa is indicated for the treatment of adults with hyperkalemia, and the Summary of Product Characteristics (SmPC) notes that this includes those who develop hyperkalemia while being treated with renin angiotensin aldosterone system (RAAS) inhibitor therapy. Nearly all patients treated with Veltassa in the clinical development program were on RAAS inhibitors at baseline. In the United States, Veltassa was approved by the U.S. Food and Drug Administration for the treatment of hyperkalemia in October 2015, becoming the first new medicine for this condition in more than 50 years. Marketing authorization applications for Veltassa have been submitted and are under review in Switzerland and Australia. Vifor Pharma plans to submit applications in other markets worldwide.

Patients with advanced CKD and/or heart failure are especially susceptible to hyperkalemia, including the 3 million people in the United States who have stage 3 or 4 CKD and/or heart failure. 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 RAAS inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs), angiotensin-converting-enzyme (ACE) inhibitors, and Mineralocorticoid Receptor Antagonists (MRA).

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 U.S. 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. 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.

Contact: Tara Cooper +1 650 303 7306 media@relypsa.com

Read at BioSpace.com


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