realtime dynamix™: hyperkalemia · agent for hyperkalemia to be approved in 50 years. veltassa...

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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 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 RealTime Dynamix: Hyperkalemia is a monthly survey of nephrologists (quarterly survey of cardiologists) focused on tracking the launch of Veltassa and following the evoluon of the hyperkalemia market. For more informaon contact [email protected]

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Page 1: RealTime Dynamix™: Hyperkalemia · 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,

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

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

RealTime Dynamix: Hyperkalemia is a monthly survey of nephrologists (quarterly survey of cardiologists) focused on tracking

the launch of Veltassa and following the evolution of the hyperkalemia market. For more information contact

[email protected]

Page 2: RealTime Dynamix™: Hyperkalemia · 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,

Invest in Intelligence That Delivers

[email protected]

Why are some CKD-ND patients with hyperkalemia NOT

candidates for Veltassa?

Allocation of 100 points

6%

9%

15%

16%

20%

24%

8%

According to nephrologists, he 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.