The drug maker told investors on Friday it has received a complete response letter - a formal rejection of approval for a new drug application – from the FDA.
The pharma group said the CRL doesn’t require it to generate any new clinical which would’ve been time consuming, instead it seems that a few “matters” need ironing out.
Resolving such issues isn’t necessarily a formality though given that this was the position the company was in when its first application was knocked back last May.
The rejections cast a shadow over AstraZeneca’s US$2.7bn acquisition of ZS Pharma back in 2015, which it primarily bought to gain access to the hyperkalaemia drug.
Still, Astra has high hopes for ZS-9 – which it reckons can generate peak sales in excess of US$1bn a year – and will come back again with a revised application.
“AstraZeneca remains dedicated to developing and commercialising sodium zirconium cyclosilicate for patients with hyperkalaemia, and is confident in the profile of this potential medicine,” the company said this morning.
“AstraZeneca and ZS Pharma are committed to working with the FDA to resolve the remaining matters under review as soon as possible.”
Although ZS-9 is thought by analysts to be a ‘core’ drug in Astra’s portfolio should it get the green light, issues surrounding it will likely take back seat this year.
The real focus in the coming months is its MYSTIC lung cancer trials, which investors should hear more on later this half.
Shares were down 0.5% to £48.40.