Enbrel: FDA Approves New Prefilled Syringe

Rheumatoid arthritis drug Enbrel just got easier! The makers of Enbrel have announced that a new 50 mg/mL prefilled syringe of Enbrel (etanercept) has been approved by the U.S. Food and Drug Administration 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. 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. Read the full press release from BusinessWire.