Topic: hyperkalemia

AstraZeneca

12. Lokelma

Lokelma was rejected twice by the FDA because of manufacturing shortfalls before finally winning the go-ahead.
AstraZeneca

6. AstraZeneca

AstraZeneca had a pretty rough few years of R&D setbacks and failures up until 2012, when its former chief, David Brennan, was all but pushed out as a result. But things seem to have steadied somewhat since Pascal Soriot took the helm.

AstraZeneca’s $2.7B ZS-9 rejected again by FDA

The FDA has rejected AstraZeneca’s hyperkalemia drug ZS-9 for the second time in 12 months. The news marks a further blow for a program AstraZeneca saw giving it a sizable share of a $6 billion (€5.5 billion) market when it acquired the asset in its $2.7 billion buyout of ZS Pharma.

AstraZeneca’s FDA delayed ZS-9 gains European thumbs-up

Held up last year at the FDA by manufacturing issues, AstraZeneca has been granted a much-needed recommendation from the EMA for its $2.7 billion hyperkalemia drug ZS-9, now known (in Europe at least) as Lokelma (sodium zirconium cyclosilicate).