CHMP gives nod to new Enbrel dosage regimen and delivery device
This article was originally published in Scrip
Executive Summary
The CHMP has adopted a positive opinion on new dosage regimens and delivery device for Wyeth's Enbrel (etanercept). The medicine, an injected tumour necrosis factor α inhibitor, is already approved in the EU for intermittent treatment of adult plaque psoriasis, among other indications. Wyeth is seeking approval of a continuous dosage regimen for plaque psoriasis – 25mg twice weekly or 50mg once weekly. They are also seeking approval of a 50mg pre-filled pen, Myclic, that they hope will ease administration of the drug.