Zerenex To Be Positioned As Cost-Saving, Oral Alternative In ESRD Setting
This article was originally published in The Pink Sheet Daily
Keryx plans to file an NDA for phosphate binder Zerenex during the second quarter, with an EU filing to follow by mid-year. In a long-term Phase III study, the candidate met its primary efficacy endpoint as well as several secondary endpoints.
You may also be interested in...
Recently-approved (and still un-trade named) phosphate binder ferric citrate could unseat the market leader due to its unique ability to increase iron in patients, firm believes, although it didn’t get the full set of labeling claims it sought.
Keryx cautions investors that a Zerenex approval is not guaranteed; NPS reports sluggish Gattex sales; Eylea sales down, but expected to rebound with new indications in the second half; Ariad’s Iclusig relaunch off to a good start.
With the field going generic and a new brand competitor with additional advantages on the way, Vifor Pharma is counting on lower pill burden to propel hyperphosphatemia drug Velphoro.