AstraZeneca has picked up FDA approval for its hyperkalaemia treatment Lokelma, allowing it to compete head-to-head with rival Vifor Pharma on both sides of the Atlantic.
Lokelma (sodium zirconium cyclosilicate or ZS-9) has been cleared by the FDA as an oral treatment for hyperkalaemia (elevated potassium levels) in adults, a potentially life-threatening condition caused by cardiovascular, renal and metabolic diseases that can lead to cardiac arrest and muscle paralysis.
AZ acquired Lokelma via the $2.7bn acquisition of ZS Pharma three years ago when the drug looked like a shoo-in for approval as the first new drug for hyperkalaemia in more than 50 years. Things quickly went awry, however, as its progress through the regulatory process was held back by manufacturing compliance issues.
That left AZ playing catch-up in the market with Vifor’s Veltassa (patiromer), which was approved in the US in 2015 and got a European green light last year and has had plenty of time to consolidate its position in the market, despite a black box warning linked to drug-drug interactions in the US at launch. AZ eventually got EU approval for Lokelma in March.
A swift effort to carry out trials to have the warning removed allowed Veltassa to remove a potential brake on sales growth, and the Swiss biotech group recorded sales of a little over $51m for the drug last year – mainly from the US as European launches only started towards the end of the year and so far include Norway, the UK, Denmark and Germany.
Vifor has also just won FDA approval for a label change to allow Veltassa to be taken with or without food, and says it is confident the drug is on track for blockbuster sales despite reports of payer resistance to covering prescriptions.
Discussing Lokelma on AZ’s first-quarter results call last week, chief executive Pascal Soriot said that the focus after FDA approval will be to work hard on “seeking access” to the US market, saying “you cannot launch these days in the US without appropriate access, otherwise you struggle”.
GlobalData has said it expects fierce competition between the two drugs as they jostle for market share, giving Veltassa an edge based on clinical data in chronic hyperkalaemia, while noting that AZ’s marketing muscle gives it a chance of overcoming its latecomer position. Meanwhile, some clinicians suggest that Lokelma could win through on a faster onset of action and greater selectivity, although there has been no head-to-head comparison of the two drugs.
In trials, the median time to achieving normal potassium levels in the blood was 2.2 hours for patients taking Lokelma,with 92% of them achieving normal potassium levels within 48 hours of the start of treatment.