Vifor Fresenius Medical Care Renal Pharma and Relypsa announce Submission of Marketing Authorisation Application Requesting European Approval of Patiromer for treatment of hyperkalemia
Monday, 25 April 2016, ↓ directly to download
Vifor Fresenius Medical Care Renal Pharma (VFMCRP), a common company of Galenica and Fresenius Medical Care, and Relypsa, Inc., a biopharmaceutical company, today announced that VFMCRP has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Patiromer*. VFMCRP is seeking approval of Patiromer (US brand name: Veltassa®) for the treatment of hyperkalemia, or elevated blood potassium levels, in the European Union (EU) through the EU centralised procedure.
Patiromer was approved by the US Food and Drug Administration (FDA) for the treatment of hyperkalemia in the US in October 2015 under the name Veltassa®, becoming the first new medicine in more than 50 years for people with elevated serum potassium.
“The MAA submission for Patiromer represents an important milestone in our efforts to bring hyperkalemia patients in Europe a new treatment option as soon as possible,” said Stefan Schulze, chief executive officer of VFMCRP. “Relypsa has been an excellent partner supporting the preparation of this robust submission, which is based on positive efficacy and safety results from an extensive clinical development program that included many patients from Europe.”
“As a recognised global leader in nephrology, VFMCRP shares our commitment to bringing Veltassa to hyperkalemia patients around the world,” said John A. Orwin, president and chief executive officer of Relypsa. “This MAA submission brings us another step closer to achieving that goal for people with hyperkalemia in Europe.”
The European submission for Patiromer is supported by data from a comprehensive clinical development program that included the following studies:
- Pivotal Phase 3 OPAL-HK study, which was conducted under a FDA Special Protocol Assessment, and evaluated Patiromer in hyperkalemic patients with chronic kidney disease (CKD) who were taking renin angiotensin aldosterone system (RAAS) inhibitors
- Phase 2 AMETHYST-DN trial, which evaluated the use of Patiromer over 52 weeks in hyperkalemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors
- An open-label, uncontrolled, Phase 1 study that evaluated the onset-of-action of Patiromer hyperkalemic CKD patients.
The European submission will undergo a formal acceptance and validation phase during May 2016 by the EMA. After this period, an official regulatory review will be undertaken.
*Patiromer stands for: Patiromer powder for oral suspension
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.
Vifor Fresenius Medical Care Renal Pharma Ltd., a common company of Galenica and Fresenius Medical Care, develops and commercialises innovative and high quality therapies to improve the life of patients suffering from Chronic Kidney Disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55% by Galenica and 45% by Fresenius Medical Care.
For more information about Vifor Fresenius Medical Care Renal Pharma and its parent companies, please visit www.viforpharma.com, www.galenica.com and www.freseniusmedicalcare.com.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialisation 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. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.
About the VFMCRP and Relypsa Partnership
In August 2015, VFMCRP and Relypsa announced that the companies had entered into an exclusive collaboration and license agreement for the development and commercialisation of Patiromer (US brand name: Veltassa®) outside the United States. Under the terms of the agreement, VFMCRP obtained an exclusive marketing right for Patiromer from Relypsa in worldwide territories except the United States and Japan, where Relypsa retains all commercial rights. Relypsa and VFMCRP are currently collaborating on ongoing development of Patiromer.
Patiromer powder for oral suspension (US brand name: Veltassa®) is an oral potassium binder approved in the US for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated serum potassium. This investigational medicine has been studied in both treatment and prevention studies, primarily in patients with CKD, and/or heart failure, as well as patients with diabetes and hypertension. Patiromer 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.
Hyperkalemia, or abnormally elevated levels of potassium in the blood, is a serious condition that can lead to life-threatening cardiac arrhythmia 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. It is frequently prevalent in patients who suffer from CKD, hypertension, diabetes and/or heart failure. Patients with CKD or heart failure are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors, which can increase blood potassium levels in patients taking these medicines.
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