European regulators have approved a label update for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalaemia in patients with end-stage renal disease on stable haemodialysis.
The decision rides on the back of findings from the Phase IIIb DIALIZE trial, which AZ says is the first-ever randomised, placebo-controlled trial to evaluate a potassium binder in patients on stable haemodialysis.
Data showed that a significantly higher proportion of patients in the Lokelma group (41.2%) met the primary endpoint and were classified as responders compared to patients in the placebo group (1.0%).
This marks the first label update for Lokelma in Europe following its EC approval in 2018 to treat adults with hyperkalaemia, and it follows a green light by the US Food and Drug Administration for the new dosing regimen last week.
By: Selina McKee
Source: Pharma Times
Echosens, a high-technology company offering liver diagnostic solutions, and Novo Nordisk A/S, a leading global healthcare company, announced a partnership to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders.
Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and quality of life measures. If approved, efgartigimod will be the first neonatal Fc receptor (FcRn) blocker for the treatment of adults in Europe living with rare neuromuscular disease generalized myasthenia gravis (gMG).
Galapagos CEO Paul Stoffels, M.D., has finally taken the plunge on M&A. The newly minted chief executive has signed not one but two deals in an attempt to right the ship, bringing two small biotechs aboard for a combined 239 million euros ($251.4 million).