ZURICH--(BUSINESS WIRE)--Regulatory News:
Vifor Pharma Group is pleased to announce the appointment of Patrick Treanor as President of Relypsa on a permanent basis. He is also appointed to the Executive Committee of Vifor Pharma Group with immediate effect. Patrick was appointed interim President of Relypsa, the US affiliate of Vifor Pharma Group on 20 September 2018.
Patrick joined Relypsa in 2015 to establish the sales organisation
for the US launch of Veltassa®. In April 2017,
he was appointed Senior Vice President and Chief Commercial Officer of
Relypsa and has been instrumental in leading the commercialisation
strategy of Veltassa® and driving Relypsa to
achieve its goal of becoming a leader in nephrology and cardio-renal
Vifor Pharma 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.
Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialization of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The company's first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalaemia in more than 50 years. More information is available at www.relypsa.com.
Approximately three million people in the United States with stage 3 or 4 chronic kidney disease (CKD) and/or heart failure have hyperkalaemia, or elevated blood potassium levels. Hyperkalaemia 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 and reduce mortality can cause hyperkalaemia as a side effect. These may 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 hyperkalaemia. Veltassa® should not be used as an emergency treatment for life-threatening hyperkalaemia 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, diarrhoea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa® and included oedema of the lips.
For Veltassa’s® full Prescribing Information, please visit https://www.veltassa.com/pi.pdf.