Immunex Plans Enbrel Early RA Consumer Ad Campaign For Summer Launch
Executive Summary
Immunex will roll out a new series of direct-to-consumer print ads to support Enbrel for early rheumatoid arthritis following FDA approval of the new indication, expected this summer.
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Enbrel Promotions May Use AUC Data, Erosion Scores, Not Superiority Claims
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Enbrel Promotions May Use AUC Data, Erosion Scores, Not Superiority Claims
Immunex' Enbrel promotions may use data on percentages of patients with no increase in erosion scores and area under the curve data, but may not use the data to make superiority claims to methotrexate, the approval letter for a new indication for Enbrel states.
Immunex Enbrel
Changes to the current vial stopper and potentially to the product delivery configuration are being evaluated following approximately 50 reports "from patients who are experiencing difficulties in penetrating the vial stopper with the needle on the supplied syringe, resulting in bent and otherwise damaged needles," firm says in recent "Dear Doctor" letter. The letter includes a revised video of instructions for preparing and administering Enbrel. The company said the letter was sent to prepare health care professionals in anticipation of Enbrel approval for the new indication of treatment of early stage rheumatoid arthritis (1"The Pink Sheet" April 24, p. 10). The user fee deadline for the sBLA is May 15