Amgen Plans to Seek FDA Approval for 3 Drugs

Amgen plans to seek Food and Drug Administration approval for three drugs in the next 12 months while starting human trials on five more, the company announced.

At its annual presentation to financial analysts in New York, the Thousand Oaks biotechnology company also said it was asking the FDA to allow the use of Neupogen for myeloid leukemia and the human immunodeficiency virus, or HIV.

Amgen received approval to use Neupogen as an HIV treatment in the United Kingdom two weeks ago and is now seeking approval throughout Europe.

“Amgen is poised to become a multiproduct company, which we believe will enable us to continue delivering attractive shareholder value into the next century,” Gordon Binder, chairman and chief executive, told the analysts.

Amgen said it expects to apply soon for approval for Infergen as a treatment for hepatitis C. If current trials are concluded successfully, it said it will also seek approval of its stem cell factor to help mobilize progenitor cells and for use of brain-derived neurotrophic factor for treatment of Lou Gehrig’s disease.

The five new drugs headed for trials this year are ob protein to treat obesity; glial-derived neurotrophic factor for Parkinson’s disease; recombinant human keratinocyte growth factor for cancer patients with mucositis; tumor necrosis factor binding protein for rheumatoid arthritis; and the Amgen cell selection device to enhance purity of cells used in transplants.