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An antianaemic medicine under evaluation by the Committee for Medicinal Products for Human Use has been approved for use in the USA.
Peginesatide, brand name Omontys®, injection has been approved by the Food and Drug Administration for treatment of anaemia due to chronic kidney disease in adults receiving dialysis.
The European Medicines Agency accepted a marketing authorisation application for the once-monthly injected, pegylated erythropoiesis-stimulating agent, in February this year.
The positive US decision was based on review of two Phase III trials that compared its safety and efficacy at maintaining serum levels of haemoglobin with those of epoetin.
Epoetin is currently approved by the EMA for treatment of anaemia symptoms in patients with chronic renal failure and in adults with certain types of cancer.
Post-marketing needs identified by the FDA include “an observational study and a randomised controlled trial to evaluate cardiovascular safety and long-term safety in the target population”, the website of the National electronic Library for Medicines states.
