September 2017: News Briefs

Veltassa Approved in European Union Market

In late July, Relypsa, Inc., announced that Veltassa® (patiromer) received approval from the European Commission for its Marketing Authorization Application. Patiromer is indicated for the treatment of hyperkalemia (elevated levels of blood potassium).

Veltassa is the brand name for patiromer in both the United States and Europe; it is approved for marketing in all 28 European Union (EU) countries and in Iceland, Liechtenstein, and Norway. In a press release, Relypsa, a Vifor Pharma Group company, announced that Vifor plans to launch Veltassa in Europe by the end of 2017 or in early 2018.

Veltassa was approved by the US FDA in October 2015 for the treatment of hyperkalemia; it was the first new medicine approved for hyperkalemia in more than 50 years. Marketing authorization applications for Veltassa have been submitted and are under review in Switzerland and Australia. There are also plans for submission of applications in other markets worldwide.

Scott Garland, president of Relypsa, said, “The European approval of Veltassa marks the first regulatory approval for this important medicine outside the United States, further validating our innovative polymer science. In the United States, 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. The Summary of Product Characteristics notes that this includes patients who develop hyperkalemia while being treated with renin angiotensin aldosterone system (RAAS) inhibitor therapy. At baseline, nearly all patients treated with Veltassa in the clinical development program were on RAAS inhibitors.

Montefiore Health System Receives NIH Research Grant

For the 42nd consecutive year, the Division of Pediatric Nephology at the Children’s Hospital at Montefiore (CHAM)/Albert Einstein
College of Medicine has received funding from the National Institutes of Health. The funding is designated for training the next generation of investigators working to create advances in science and discovery related to kidney health. The $1.2 million T32 training grant will be used to fund postdoctoral fellows and CHAM/Einstein over 5 years, protecting their time to conduct research.

Over the past 42 years, NIH funding has benefited more than 50 postdoctoral trainees at CHAM/Einstein, providing them with mentorship and guidance from the CHAM/Einstein researchers as they worked together on a variety of translational and clinical research projects leading to improved care for children with kidney disorders and diseases, according to a press release from the Montefiore Health System.

Renal Dialysis Device Market Expected to Grow to $26 Billion

In 2016, renal dialysis equipment accounted for more than 55% of the market value of the nephrology and urology devices market. Dialysis-related equipment totaled more than $17 billion, and is expected to grow to more than $26 billion by 2026. According to a press release from GlobalData, nearly 60% of renal dialysis patient growth will be driven by the emerging markets of China, Brazil, and India, which is expected to account for 48% of the population of patients on dialysis by 2026.

Andrew S. Thompson, PhD, director of therapy and analysis for medical devices at GlobalData, said, “This report indicates that renal dialysis equipment will maintain a lead in the nephrology and urology devices market; however, incontinence devices are an area to watch out for, given the projected increase in demand, coupled with a healthy product pipeline. For companies operating in the renal dialysis space, this level of growth presents a huge opportunity to maintain their competitive advantage by driving volume and value sales and profitability.”

Refusal Rates of Deceased Donor Kidneys Vary Widely

In a recent study reported in the Clinical Journal of the American Society of Nephrology, researchers found that kidneys from deceased donors are typically offered and declined many times prior to being accepted for transplantation. In addition, the study found differences in such refusals according to patient and donor characteristics and may be a contributing factor in racial and ethnic disparities in access to transplantation.

The researchers analyzed data on the seven million deceased donor adult kidney offers in the United States from 2007 to 2012 that led to eventual transplantation. The study population included 178,625 patients who were waitlisted for a deceased-donor kidney transplant and 31,230 deceased donors.

In the current study, kidneys from deceased donors were offered for transplantation a median of seven times before being accepted for transplantation. The most common reasons for refusal were factors related to the donor (age or donor quality) or because the minimal acceptable criteria for a transplant center were not met. After adjustment for waitlisted patient characteristics, donors, and transplant centers, male and Hispanic patients were 7% and 4% less likely to have kidneys accepted for them for transplant compared with female and white patients, respectively. There was wide variation in the likelihood of offer acceptance across transplant centers.

In an article in Medical News Today, Anne Huml, MD, lead author of the study, said, “By recognizing these differences, centers may be able to evaluate their acceptance practices to have the greatest impact on shortening times. Gaining a better understanding of offer refusals may also allow policy makers to develop and disseminate information about best practices to centers with low acceptance rates.”

Post-ED Discharge Mortality and AKI

Thirty-day outcomes among patients discharged from the emergency department with acute kidney injury (AKI) tend to be poor; poor outcomes include increased risk of mortality, according to a retrospective review of medical records reported in the Clinical Journal of the American Society of Nephrology.

Patients with AKI upon discharge were 60% more likely to die within 30 days compared with those without AKI (relative risk [RR], 1.60; 95% confidence interval {CI], 1.2-2.0; P=.001). Patients excluded from the study were those admitted to the ED specifically for AKI. Another study finding demonstrated that patients discharged from the ED with AKI were less likely to die within 30 days compared with those with AKI who were hospitalized (RR, 0.30; 95% CI, 0.2-0.3; P<.001).

In an article on Medpage Today, the researchers said, “These findings highlight the accuracy of ED clinicians in discerning subtle clinical differences in patients with AKI. Sicker patients destined for worse outcomes were appropriately hospitalized. Nonetheless, the adverse outcomes of AKI following an ED discharge are clearly highlighted when such patients were compared to a similar cohort of patients without AKI.”