Rockwell Sees Opportunity For Triferic In Cost-Sensitive CKD Market
This article was originally published in The Pink Sheet Daily
Rockwell Medical has filed an NDA for the iron replacement therapy, which will be positioned as an alternative to I.V. iron during dialysis and could limit the need for erythropoietin-stimulating agents.
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Also, Rockwell’s iron deficiency treatment Triferic gains agency approval, but without a dose-sparing claim related to erythropoiesis-stimulating agents; Symplmed’s perindopril/amlodipine fixed-dose combination approved for hypertension.
Oncologic Drugs Advisory Committee endorses approval of Rockwell’s Triferic, but for only half of proposed indication; support tempered by “artificial” nature of Phase III studies, a claim to which Rockwell’s CMO agreed.
Rockwell’s iron replacement therapy could be hindered by absence of ESA-reduction claim even if drug makes it through FDA with more limited indication; agency will have to address its own discrepancies in briefing document data at the Nov. 6 Oncologic Drugs Advisory Committee.