June 27, 2014

Avonex® PenTM Autoinjector Approved by Health Canada

Biogen Idec. Canada announced Health Canada’s approval to market a new convenient autoinjector, Avonex Pen, for treatment of people with relapsing forms of multiple sclerosis and those with a single demyelinating event. Avonex Pen is the first single-use; once-a-week, intramuscular autoinjector designed specifically to improve convenience of treatment and ease injection anxiety.

Biogen Idec. Canada has developed a new convenient administration for the MS disease modifying therapy, Avonex (interferon beta 1-a). Avonex Pen is the first single-use; once-a-week, intramuscular, autoinjector available for treatment of people with relapsing forms of MS. Specialized features of the autoinjector pen include an injector shield which hides the needle prior to injection, automated needle insertion and medication delivery, confirmation of completed medication delivery through a display window on the pen and a safety lock to prevent possible injection error.

Avonex (interferon beta-1a) is a type of protein called a beta-interferon that is produced from mammalian cells using recombinant DNA techniques (a series of procedures used to join together DNA segments). In MS, the main effects of Avonex are to block the activity of certain immune system cells and to reduce the passage of these immune cells into the central nervous system, where they cause inflammation and damage to myelin.

The most common side effects of Avonex therapy include flu-like symptoms such as fatigue, chills, fever, muscle aches and sweating. Less common side effects include injection site reactions (swelling, redness, discolouration and pain), some liver, blood and thyroid problems, allergic reactions and depression.

Health Canada approved Avonex Pen based in part on a Phase 3b open-label (both researchers and participants were aware of the treatment being administered), multi-centre study which evaluated the safety and efficacy of Avonex Pen. The study included participants with MS who had been using Avonex PS (pre-filled syringe) for at least 12 weeks prior to study enrollment. Efficacy of Avonex Pen was assessed through objective and subjective reporting from key aspects of participants’ use of the single-use autoinjector. In the study, overall success rate in participants with MS using Avonex Pen was 89 percent, and 94 percent of participants expressed a preference for Avonex Pen over Avonex PS.