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Biotech / Medical : Celltech Group (NYSE: CLL) -- Ignore unavailable to you. Want to Upgrade?


To: keokalani'nui who wrote (58)12/23/2002 11:19:51 AM
From: keokalani'nui  Read Replies (1) | Respond to of 123
 
Is this still 2 injections per week?

Amgen Submits Data to FDA Supporting Once-Weekly Dosing of ENBREL(R)
Monday December 23, 8:30 am ET

THOUSAND OAKS, Calif., Dec. 23 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN - News) today announced that it has submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) supporting once-weekly dosing of ENBREL® (etanercept).

"This is another important milestone in the development of ENBREL," said Dr. Beth Seidenberg, Amgen's senior vice president of development. "Not only does ENBREL have the broadest range of indications to treat rheumatic diseases, but this latest application may offer patients dosing flexibility."

The filing is based on results from a Phase 3 study demonstrating that patients treated with 50 mg of ENBREL once weekly achieved similar efficacy, tolerability and pharmacokinetics when compared to patients receiving 25 mg of ENBREL twice weekly.