Amgen/Wyeth Enbrel once-weekly sBLA
This article was originally published in Pharmaceutical Approvals Monthly
Amgen files for once-weekly dosing for its anti-TNF receptor Enbrel (etanercept) Dec. 20, based on a Phase III study showing that 50 mg etanercept once-weekly had similar efficacy, tolerability and pharmacokinetics as 25 mg etanercept twice-weekly. The newest entrant in the class, Abbott's Humira, has a once-weekly dosing regime
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