AstraZeneca receives FDA approval for Lokelma

After FDA rejections in May 2016 and March 2017 and 2 months after gaining the European go-ahead, AstraZeneca’s Lokelma, used to treat hyperkalemia, has received FDA approval. 

The two delays, due to manufacturing issues at a Texas plant, allowed Vifor Pharma’s Veltassa to gain speed as the only drug available to treat hyperkalemia. Even with sole control of the market Veltassa grew from $12.5 million in 2016 to $52.7 million in 2017 sales. 

Hyperkalemia is most common in patients with poor kidney function and heart failure and can be fatal. With few options for treatment, that's one reason AZ thought ZS Pharma would be worth its $2.7 billion purchase price. 

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