Biogen Idec received FDA clearance for its AVONEX PEN, a device for injecting AVONEX (Interferon beta-1a) into the thigh.
The device may be a more convenient and less frightening option over traditional prefilled interferon syringes.
From the press release:
AVONEX PEN (AVONEX 30mcg/0.5mL solution for injection) is an automated injection device designed to be easier to use than the currently available AVONEX Prefilled Syringe. AVONEX PEN also incorporates a substantially smaller needle, which may reduce injection anxiety and pain. AVONEX PEN was approved based on data from a Phase 3b study in which approximately nine out of 10 patients used the device successfully. Ninety-four percent of patients in the study also expressed a preference for AVONEX PEN over the AVONEX Prefilled Syringe. AVONEX PEN was approved in the European Union and Canada in 2011.
The updated prescribing information also provides physicians and patients with a regimen to titrate therapy at treatment initiation to reduce the incidence and severity of flu-like symptoms. This optional titration schedule, which can be facilitated by the new AVOSTARTGRIP™ devices, 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 percent, as well as significantly reduced the flu-like symptom incidence, versus no titration four to six hours post-injection. After the titration period, patients may continue treatment with AVONEX PEN or other administration options.
Here’s a Youtuber demonstrating the AVONEX PEN:
Press release: FDA Approves AVONEX® PEN™ and Dose Titration Regimen…