Cambridge, U.K.-based AstraZeneca PLC said its hyperkalemia treatment Lokelma secured marketing approval from the European Commission.
Hyperkalemia is a condition characterized by elevated potassium levels in the blood associated with cardiovascular, kidney and metabolic diseases.
The oral potassium-removing agent was initially given a positive opinion by the EMA in February 2017. However, the European Commission suspended its decision after some concerns relating to good manufacturing practices at the manufacturing site for the active substance and referred the matter back to the agency.
EMA later gave a positive nod to the treatment in January.
The approval is supported by three late-stage clinical trials where patients with hyperkalemia were treated for up to 12 months. The drug statistically demonstrated desired levels of potassium control in the blood of subjects.
Lokelma is also under review in the U.S., with a decision expected during the first half of 2018.