Amgen, Inc.

Biologics License Application submitted for FDA approval of Palifermin

Published in Oncology Business Week, July 25th, 2004

Amgen, Inc., (AMGN) announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for palifermin, a first-in-class investigational compound in development by Amgen for oral mucositis (mouth sores).

The potential therapeutic indication is to reduce the incidence, duration and severity of oral mucositis in patients with hematologic malignancies undergoing high-dose chemotherapy, with or without irradiation, followed by a bone marrow transplant.

Approximately 11,000 Americans with hematologic malignancies, including non-Hodgkin lymphoma, Hodgkin disease, leukemia and multiple myeloma, undergo bone marrow...

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Source: Oncology Business Week (2004-07-25)

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