Takeda Pharmaceutical Co and Affymax are celebrating after getting the green light from regulators in the USA for their anaemia drug Omontys.
The US Food and Drug Administration has approved Omontys (peginesatide) for the treatment of anaemia due to chronic kidney disease (CKD) in adults on dialysis. The thumbs-up was expected given that at the end of last year, the agency's Oncologic Drugs Advisory Committee voted 15 to one in favour of the synthetic, pegylated peptidic compound that acts as an erythropoiesis stimulating agent, the same class as Amgen’s treatments Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and Johnson & Johnson's Procrit/Eprex (epoetin alfa).
The FDA’s decision is based primarily on two Phase III studies which compared Omontys dosed once monthly, compared to epoetin dosed between one-to-three times per week in maintaining haemoglobin levels in anaemic CKD patients on dialysis. The late-stage programme was also the first to compare head-to-head the cardiovascular safety of different ESAs.
Noting that the studies showed Omontys was as safe and effective as epoetin, Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, noted that the drug is "represents the first new FDA-approved and marketed ESA for this condition since 2001”. He added that it offers "patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections".
The agency has approved Omontys with a risk evaluation and mitigation strategy, and asked for an observational study and a randomised controlled trial to be completed with final reports submitted in 2018 and 2019, respectively. The studies will evaluate cardiovascular safety and long-term use in adults on dialysis.
In addition, the post-marketing commitment includes the initiation of paediatric studies with target dates for completion between 2016 and 2027. John Orwin, Affymax chief executive, noted that "for over two decades, doctors have relied primarily on one erythropoietin-based treatment in the dialysis setting. With Omontys, doctors and patients will have access to a once-monthly alternative".