Long sidelined on manufacturing penalties, AstraZeneca finally gets a green light for a potential hyperkalemia blockbuster
After being forced to the sidelines as Vifor cleaned up its problems with its hyperkalemia drug Veltassa and burnished hopes for big sales, AstraZeneca is finally in business and ready to take the field with a rival marketing team.
The FDA has approved AstraZeneca’s rival drug ZS-9, to be sold as Lokelma, after twice spurning the drug application due to manufacturing issues.
That’s not what the pharma giant had been thinking when it snapped up the late-stage drug in the $2.7 billion ZS Pharma buyout three years ago. Its repeated setbacks at the agency underscored the company’s frequent development pratfalls in recent years, particularly outside of the oncology arena. But the pharma heavyweight now has a chance to redeem itself with an aggressive sales effort as revenue from its mainstay franchise drug Crestor crumbles in the face of generic competition.
Analysts were ready to give AstraZeneca’s drug the edge in the marketing wars to come, noting some key advantages for Lokelma. Coming in well behind the first-mover in the field, AstraZeneca will need all the help it can get.
“Whilst we must concede the label is not a best-case, we nonetheless see it as an improvement on the only incumbent option, Vifor’s Veltassa,” Barclays analysts said in a note, according to a report in Reuters. “Our thesis remains that Lokelma will be the dominant player in the eventual $3 billion hyperkalemia market.”
The drug is designed to clean up excess levels of potassium, a condition that afflicts patients with heart disease and chronic kidney disease.
“We are pleased by today’s FDA approval of Lokelma as it enables us to help address a long-standing clinical need with a new medicine that offers rapid and sustained treatment for adults with hyperkalemia,” noted AstraZeneca’s Sean Bohen. “The consequences of hyperkalemia can be very serious and it’s reassuring for treating physicians that Lokelma has demonstrated lowering of potassium levels in patients with chronic kidney disease, heart failure, diabetes and those taking RAAS inhibitors.”