FDA Approves Avonex Pen and Dose Titration Regimen
Biogen Idec has received approval from the FDA for Avonex Pen (30mcg/0.5mL solution for injection) for patients receiving once-a-week Avonex (interferon beta-1a) for relapsing forms of multiple sclerosis (MS). Avonex Pen is a single-use, once-a-week, fully integrated IM autoinjector.
The Avonex Pen is an automated injection device designed to be easier to use with a smaller, thinner needle (25 gauge, 5/8 inch) that is 50% shorter than the standard Avonex prefilled syringe needle currently available. Additional features of the Avonex Pen include: a protective injector shield that conceals the needle prior to injection; automated needle insertion and medication delivery; and a safety lock, which helps prevent injection error and a display window that confirms complete delivery of the medication. This new design may reduce possible injection anxiety and pain. The efficacy and safety of Avonex Pen was evaluated in a Phase 3b, open-label, multicenter study. Efficacy was assessed through objective and subjective assessments of key aspects of patients' use of the pen.
Additionally, the FDA has also approved updated prescribing information that provides a dose titration regimen at treatment initiation to reduce the incidence and severity of flu-like symptoms. This regimen is based on data from an eight-week, randomized, healthy-volunteer study that showed a three-week titration period at treatment initiation reduced the severity of flu-like symptoms by 76%, as well as significantly reduced the flu-like symptom incidence, versus no titration four to six hours post-injection.
For more information
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