Auxilium's Xiaflex Clears FDA With REMS To Educate Doctors On Safe Injection Techniques
This article was originally published in The Pink Sheet Daily
Executive Summary
REMS does not restrict type of physician who can administer the collagenase enzyme, which will launch in March.
You may also be interested in...
Auxilium’s Peyronie’s Strategy: Start With Few Urologists, Broad Patient Population
Xiaflex is first drug approved for Peyronie’s disease; initial marketing will focus on physicians that already provide invasive treatment.
Pfizer Rare Disease Plans Back On Track With Resubmission of Tafamidis
Pfizer gained the therapy to treat a rare genetic neurologic disorder in its 2010 acquisition of folded protein company FoldRx.
Auxilium Revamps Commercial Strategy For Xiaflex
The manufacturer expected Xiaflex to take off as a non-invasive, more effective alternative to hand surgery, but the market has been slow to convert, prompting Auxilium to shift around its commercial organization.