Aranesp Extended Dosing Approval Could Provide Advantage Over Procrit In Chemo Market
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA clears a supplemental BLA for every-three-week dosing of darbepoetin alfa in chemotherapy-induced anemia patients.
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Aranesp 's new dosing regimen could give the red blood cell factor an advantage over Johnson & Johnson's Procrit in the chemotherapy-induced anemia market. FDA approved a supplemental BLA for an every-three-week dosing regimen for Aranesp (darbepoetin alfa), Amgen announced March 27. The recommended starting dose for the new regimen is 500 mcg. Amgen noted that the two dosing options will allow patients to have their anemia treatment synchronized with both weekly and every-three-week chemotherapy regimens, which the firm said are the most common treatment schedules. Procrit (epoetin) is approved only for weekly dosing. Until recently, Amgen and J&J had been in a pricing war in the chemotherapy-induced anemia market. J&J filed suit against Amgen alleging use of anti-competitive contracting strategies to drive usage of Aranesp (1 (Also see "J&J Expects EPO Pricing Injunction Ruling In Early 2006" - Pink Sheet, 18 Oct, 2005.)). Amgen has also highlighted the extended dosing regimen for Aranesp as a way of differentiating Aranesp should epoetin generics enter the market. -Andrew Kasper |