RealTime Dynamix™: Hyperkalemia 2016


RealTime Dynamix™: Hyperkalemia

Spherix Global Insights has been following the development of the hyperkalemia market since June 2015, in advance of the FDA approval of Veltassa (patiromer FOS), the first agent for hyperkalemia to be approved in 50 years. Veltassa was launched in the US in January 2016 and is expected to face competition from ZS-9, another novel potassium binder in development by ZS Pharma (acquired by AstraZeneca in 2015). ZS Pharma was dealt a blow on April 26, 2016 when, instead of being approved, was issued a Complete Response Letter. Stay tuned on how this may impact the market.

According to 112 Nephrologists surveyed in late April 2016, Veltassa offers promise, efficacy and innovation, but comes at a cost

Percent of Physicians Using Veltassa
By Setting


Excited to Try…Four months post-launch more than half of the surveyed nephrologists (left) report starting patients on Veltassa, primarily in the CKD-ND outpatient setting.

Cardiologists report a more muted response and the introduction of Veltassa is less top of mind for this specialty.

Why are some CKD-ND patients with hyperkalemia NOT
candidates for Veltassa?
Allocation of 100 Points


Unaided Disadvantages (number of mentions) January February March April
Dose separation, drug-drug interactions 27 23 41 46
Cost and access concerns 26 38 26 40
Other 3 9 3 9
GI issues 8 4
Not for acute hyperkalemia 9 2 6 4
Delayed onset of action 9 8 2 2
New unknown 12
Administraion issues 8

According to nephrologists, the black box warning about DDIs recommending a six hour dose separation as well as reimbursement woes are perceived to be disadvantages and the major barriers to expanded use.

On May 25, 2016 Relypsa filed new data with the FDA seeking to change the label to reflect updated drug interaction data and reduce the six hour recommendation to a three hour recommendation. Our research suggests that, if approved, this will augment use of the product.

Happy with the availability of at least one hyperkalemia agent, desire for new agents shifts away from ZS-9 to AbbVie’s atrasentan, in Phase 3 trials for diabetic nephropathy. (n=112)

After being asked about familiarity with renal pipeline agents (right), nephrologists were asked which one they would most like to see approved.

Most Desired Pipeline Agent