Relypsa’s Veltassa Dodges the Competition Bullet as FDA Hands AstraZeneca a Second Complete Response Letter for Hyperkalemia Agent, ZS-9
Delay gives Relypsa time to close the nephrology-to-cardiology gap for Veltassa
March 21, 2017 – Cambridge, Massachusetts. Sixteen months and $2.7 billion ago, ZS Pharma’s hyperkalemia candidate (ZS-9, sodium zirconium cyclosilicate) was one of the most highly anticipated drugs in the renal market. Since being acquired by AstraZeneca, the company last week received a second Complete Response Letter for ZS-9, delaying approval yet again and leaving a wide-open runway for Veltassa, its lead competitor which launched in January 2016.
According to the latest RealTime Dynamix: Hyperkalemia, Q1 2017 report, there is a sharp divide between nephrologists and cardiologists when it comes to the use of Veltassa. On the one hand, cardiologists tend to be more conservative in their management, intervening at lower elevations of serum potassium compared to their nephrology colleagues. However, even with earlier intervention for hyperkalemia, Veltassa trial rates significantly lag those of nephrologists, despite the two specialties seeing a similar volume of patients. Relypsa’s promotional efforts appear to be having impact on Veltassa trial and adoption, with 85% of the cardiologists called on by a sales representative having prescribed the product. However, the reach in the cardiology setting has been at a deficit to that observed in nephrology, where the vast majority of physicians have been both called on and are active prescribers.
With ZS-9 off the table, at least for the near term, Relypsa can turn its attention to addressing some of the barriers to initiating patients on Veltassa, such as the wait-and-see attitude of physicians, market access limitations and the logistical issues of obtaining the product via speciality pharmacy. In addition, Relypsa needs to attend to the growing barrier of maintaining patients on Veltassa long-term, as an increasing percent of Veltassa discontinuations are related to the physician’s original intention of short-term use. Addressing these issues will enable Veltassa to become more entrenched, raising the barrier to market entry for ZS-9, when and if it is ultimately approved.
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