AMAG’s Feraheme Expansion Strategy Delayed For Now
This article was originally published in The Pink Sheet Daily
FDA has extended by three months its review of a sNDA for the I.V. iron product that would expand the drug’s use into a far broader patient population.
You may also be interested in...
Luitpold citizen petition seeking to block AMAG’s expanded indication for injectable iron offers FDA an opportunity to weigh in on how similar trial designs must be for drugs with the same indication.
AMAG is looking to build out its portfolio by in-licensing or acquiring new commercial products that complement its I.V. iron product Feraheme. The company is in negotiations for multiple assets, while at the same time preparing to launch Feraheme into a broader patient population.
The market for kidney disease drugs is under pressure from Medicare cost containment policies. However, there is still room for new drugs – if they can demonstrate a cost-savings benefit.