FDA Approves New and Easy Way to Take ENBREL

September 28, 2004 04:05 PM US Eastern Timezone

Source: http://home.businesswire.com

FDA Approves New and Easy Way to Take ENBREL; Benefits of ENBREL Delivered
in Convenient Once-Weekly 50 mg/mL Prefilled Syringe

THOUSAND OAKS, Calif., & COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Sept. 28,
2004--Amgen Inc. (NASDAQ:AMGN) and Wyeth Pharmaceuticals, a division of
Wyeth (NYSE:WYE), today announced that the new 50 mg/mL prefilled syringe of
Enbrel(R) (etanercept) has been approved by the U.S. Food and Drug
Administration (FDA) as the recommended dosing form for treatment in all
approved adult indications. The new prefilled syringe, available for patient
use in the fourth quarter 2004, will eliminate the need to mix drug prior to
injecting and allows most patients receiving ENBREL to take only one
injection per week, instead of the two 25 mg injections currently used
weekly by patients.

"Since the rheumatoid arthritis approval in 1998, ENBREL has helped
thousands of people better manage their disease," said Beth Seidenberg,
M.D., chief medical officer and senior vice president of global development,
Amgen. "This approval provides physicians with the opportunity to offer
their patients an easy-to-use prefilled syringe that delivers the same drug
patients and physicians have grown to trust."
The FDA approval was based on a study, which found that the ENBREL 50 mg/mL
prefilled syringe was shown to be biologically equivalent to two 25 mg
vials. The 25 mg formulation will still be available for juvenile rheumatoid
arthritis patients and those that prefer that dosing method.