Amgen Palifermin BLA For Mucositis Builds On Supportive Care Franchise; Priority Review Expected
This article was originally published in The Pink Sheet Daily
Executive Summary
The BLA covers reduction in incidence, duration and severity of oral mucositis in patients with hematologic malignancies undergoing bone marrow transplants. Estimated patient population is 11,000 – planned supplements for solid tumor markets will bring market to 400,000.
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Amgen Will Launch Palifermin In Late January Under Brand Name Kepivance
The oral mucositis treatment clears FDA under priority review. Labeling includes the precaution that "Kepivance has been shown to enhance the growth of human epithelial tumor cell lines in vitro." Palifermin's safety and efficacy were assessed in two studies examining 381 patients.
Amgen Will Launch Palifermin In Late January Under Brand Name Kepivance
The oral mucositis treatment clears FDA under priority review. Labeling includes the precaution that "Kepivance has been shown to enhance the growth of human epithelial tumor cell lines in vitro." Palifermin's safety and efficacy were assessed in two studies examining 381 patients.
Amgen Expects Palifermin BLA To Clear FDA Shortly
Oral mucositis agent is receiving a "fast track" review, and Amgen is understood to be awaiting word from FDA in the next few days.