Hyperkalemia describes elevated levels of serum potassium, which if left untreated, cause cardiovascular complications, resulting in abnormal cardiac function and increased mortality. According to Decision Resources Group’s primary research based on 100 U.S. nephrologists1, 60% of surveyed physicians indicated that pharmacological treatment for hyperkalemia should be initiated at a serum potassium level of between 5.51 mEq/L and 6.00 mEq/L. Hyperkalemia can occur for a number of reasons, including renal disease, diabetes, and treatment with medications such as renin–angiotensin–aldosterone system inhibitors.

The Food & Drug Administration (FDA) approved sodium polystyrene sulfonate (SPS)/Kayexalate for the treatment of hyperkalemia nearly 60 years ago – the only approved hyperkalemia treatment until 2015. One problem with Kayexalate is the FDA warning of intestinal necrosis2, a side effect which can be fatal. The product is also typically prescribed in the acute setting. Thus, there is a need for hyperkalemia therapies that can safely lower serum potassium levels in a rapid and sustained manner in both acute and chronic settings.

The FDA approved Relypsa’s Veltassa to treat hyperkalemia on October 21, 20153. Relypsa since entered into a two-year detailing agreement with Sanofi to promote Veltassa in the U.S.4, and Relypsa and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) have agreed to commercialize Veltassa in Europe5. On September 2, 2016, Galenica completed its acquisition of Relypsa6, and Relypsa’s operations are expected to fold into Galenica’s VFMCRP unit7. In our study fielded during July 5 – July 14, 20161, the majority of the surveyed nephrologists reported they were approached by sales representatives for Veltassa within the last six months. Half of these physicians were highly satisfied with Veltassa’s sales representatives’ performance and most often recalled efficacy as the key message from Veltassa’s representatives.

Veltassa has been available to patients in the U.S. since December 21, 20158 and according to surveyed nephrologists1, over 15% of hyperkalemia CKD patients are on Veltassa, and close to 30% of their patients with serum potassium levels of 5.51 mEq/L or above are on the drug. This rapid uptake of Veltassa in under seven months of availability is impressive to say the least. A slower uptake was expected for Veltassa as physicians become more comfortable with it as a chronic treatment, its requirement for prescribing through a specialty pharmacy hub, Veltassa K+onnect9, and the number of drug-drug interactions10 associated with its use. In-depth analysis of factors that drive and constrain Veltassa treatment, as well as Veltassa patient shares based on CKD stage and serum potassium levels, are presented in Decision Resources Group’s Current Treatment: Bone and Mineral Metabolism (BMM) Disorders Q3 2016 insights1.

 

1Decision Resources Group’s CurrentTreatment® BMM Disorders Q3 2016 (US) provides a deep dive and longitudinal information on the BMM disorder market dynamics. It examines the management of dialysis and mid-to late-stage CKD patients from the perspective of 100 U.S. nephrologists with emphasis on hyperphosphatemia, secondary hyperparathyroidism, and hyperkalemia. Also included in this content are sales and messaging efforts of key market players and coverage of late-stage products for the treatment of BMM.

2http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm186845.htm

3http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468546.htm

4http://investor.relypsa.com/releasedetail.cfm?releaseid=926942

5http://www.viforpharma.com/en/Media/mediareleases/2016/20160425_5802227825-message.php

6http://www.galenica.com/en/medien/medienmitteilungen/2016/20160902_3046390678_meldung.php

7http://www.galenica.com/en/medien/medienmitteilungen/2016/20160804_8321945884_meldung.php

8http://files.shareholder.com/downloads/AMDA-29YRKX/1993943336x0xS1193125-16-475780/1416792/filing.pdf

9https://www.veltassa.com/supportservices/hcp/

10https://www.veltassa.com/pi.pdf

How Glympse Bio oversubscribed their Series B funding amidst the pandemic

View Now