12. Lokelma

AstraZeneca
(AstraZeneca)

Active ingredient: sodium zirconium cyclosilicate 
Disease: hyperkalemia 
Peak sales estimate: over $1 billion  
Approved: May 18 
Company: AstraZeneca

The scoop: AstraZeneca’s potential blockbuster hyperkalemia drug Lokelma, formerly known as ZS-9, was rejected twice by the FDA because of manufacturing shortfalls before finally winning the go-ahead. AZ paid $2.7 billion to acquire Lokelma’s developer, ZS Pharma, in 2015 in the hope that the drug could soon start on a journey to $1 billion-plus in peak sales. But the regulatory delays benefited competitor Vifor Pharma’s Veltassa, which was approved in October 2015. Veltassa first came with a black-box warning, only to be removed by the FDA in 2016. However, the Vifor drug only generated $52.7 million in 2017 sales. Credit Suisse analyst Vamil Divan, M.D., has said that the AZ drug “has an overall stronger clinical profile than Veltassa.” Data from five clinical trials showed that Lokelma could reduce high potassium levels in the blood in an hour and restore it to normal levels in about two hours. — Angus Liu

12. Lokelma
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