Affymax Once-Monthly ESA Will Target Smaller Dialysis Centers
This article was originally published in The Pink Sheet Daily
Executive Summary
Omontys (peginesatide) launches for chronic kidney disease patients on dialysis, while non-dialysis patients were not included in the labeling due to CV event risk. Pricing negotiations will commence following the March 27 approval.
You may also be interested in...
Affymax Considers Bankruptcy As Omontys Investigation Continues
Affymax cuts staff in order to conserve the little cash it has left in its coffers, which will be needed to pay down debts and continue looking into safety issues surrounding its sole commercial product – an investigation that may never be concluded because the company lacks resources.
Affymax's Peginesatide May Be Tough Sell To ODAC As ESAs Cast Long Showdow
Safety concerns over erythropoiesis-stimulating agents seem to extend to Affymax's peginesatide, and since it lacks an efficacy edges over these drugs in treating anemia due to chronic kidney disease, an approval basis is unclear.
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.