AstraZeneca has at long last won EU approval for Lokelma as an oral treatment for high potassium levels, more than a year after it was backed by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Lokelma (sodium zirconium cyclosilicate or ZS-9) has been approved for adults with hyperkalaemia, a potentially life-threatening condition which can cause cardiac arrest and muscle paralysis, allowing it to finally challenge Vifor Pharma’s Veltassa (patiromer) which was approved in the EU last year and has been sold in the US since 2015.
AZ’s product has been blocked by problems at its manufacturing facility for Lokelma in Coppell, Texas, which resulted in two FDA complete response letters from the US regulator last year, delaying approval and giving Vifor time to consolidate its position in the market. The company says it is expecting an FDA verdict “in the first half of 2018” thanks to a positive inspection of the plant.
For its part, Vifor has said securing payer coverage for Veltassa in the US has been a little slow, but is gaining momentum with sales of Veltassa in that market rising fourfold to more than $50m last year. It was approved in the EU last July and as of the end of 2017 had been launched in the UK, Norway and Denmark.
The risk of hyperkalaemia increases significantly for patients with chronic kidney disease (CKD) and for those who take certain heart failure (HF) medicines that increase potassium levels in the blood. Drug therapy is often modified or discontinued in HF patients as a result, but this can increase the risk of death.
The European approval finally puts AZ on course to make a return from its $2.7bn purchase of Lokelma’s originator ZS Pharma in 2015, when the drug had already been submitted for approval. At the time, AZ chief executive Pascal Soriot said hyperkalaemia “is underappreciated and prevalence is increasing” and that the drug had sales potential in excess of $1bn a year. AZ’s marketing muscle will no doubt come into play if US approval comes through and the two drugs start to compete on a level playing field.
“The consequences of hyperkalaemia can be serious, even life-threatening, and can occur in patients either with CKD or as a result of taking some medications for heart failure,” commented Elisabeth Björk, who heads up AZ’s cardiovascular, renal and metabolism drug development.
The approval of Lokelma “addresses a significant unmet need by bringing a rapid and sustained therapeutic option for patients with hyperkalaemia,” she added. AZ has suggested that its clinical data indicates Lokelma has a faster onset of action than Veltassa and is more selective, although as of yet there are no head-to-head comparisons of the two treatments.