Biogen (BIIB) Announces Approval of AVONEX PEN, Dose Titration Regimen from FDA

Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX for relapsing forms of multiple sclerosis (MS).

• AVONEX PEN, the first intramuscular (IM) autoinjector approved for MS, incorporates a smaller needle and easier administration to help patients reduce anxiety about AVONEX self-injection.
  
• A new dose titration regimen, which gradually escalates the dose of AVONEX at treatment initiation, reduces the incidence and severity of flu-like symptoms that can occur at the beginning of therapy.

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.

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