Amgen Files for FDA Approval of Aranesp

Amgen Inc. filed for government approval to market Aranesp, its next-generation anemia drug, for treatment of chemotherapy-induced anemia, a potential $4.7-billion market. The application is expected to be approved a year from now.

Analysts expect off-label use of Aranesp in advance of FDA action because its price compares favorably with that of Procrit, a first-generation anemia treatment marketed by Johnson & Johnson.

A weekly dose of Aranesp, as suggested by Amgen-sponsored research involving cancer patients, costs about $400 compared with $445 for Procrit.

The federal agency this week approved Aranesp to treat anemic kidney disease patients. In that market, because of dosing differences, Aranesp has no price advantage over Procrit or Amgen’s first-generation treatment, Epogen.

Amgen shares rose $1.05 to close at$59 on Nasdaq.