Biogen Idec announces availability of two new AVONEX dosing innovations for MS

Biogen Idec (NASDAQ: BIIB) announced that two new dosing innovations designed to help patients receiving once-a-week AVONEX (interferon beta-1a) for relapsing forms of multiple sclerosis (MS) are now available in U.S. pharmacies:    

• The new AVONEX PEN (AVONEX 30mcg/0.5mL solution for injection) is the first intramuscular (IM) autoinjector for chronic use, designed to enhance the self-injection process for patients receiving AVONEX therapy.
• A new dose titration regimen, facilitated by the AVOSTARTGRIP titration devices, provides patients with the option to gradually increase the dose of AVONEX at treatment initiation to reduce the incidence and severity of flu-like symptoms that patients may experience with therapy.

These product enhancements offer the potential for a more tolerable initiation and an easier injection process compared to the AVONEX Prefilled Syringe.

"It is our priority to continue to improve our existing treatments like AVONEX, which patients have relied on to effectively treat their MS since it was approved in the U.S in 1996," said Douglas E. Williams, Ph.D., Biogen Idec's executive vice president of Research and Development. "AVONEX PEN has been shown to help reduce the anxiety patients may experience when self-injecting and for patients initiating treatment, titration can reduce the flu-like symptoms they may have when beginning AVONEX therapy."

AVONEX PEN is the first IM autoinjector approved in MS treatment. It was designed to enhance the self-injection process and features a substantially smaller needle than the AVONEX Prefilled Syringe. The U.S. Food and Drug Administration (FDA) approved the AVONEX PEN in February 2012 based on data from a Phase 3b study in which approximately nine out of 10 patients used the device successfully. In this study patients felt significantly less injection pain after they switched from the Prefilled Syringe to AVONEX PEN and the patients experienced reduced injection anxiety with AVONEX PEN than with the Prefilled Syringe. Ninety-four percent of patients in the study also expressed a preference for AVONEX PEN over the AVONEX Prefilled Syringe. The top three reasons for this preference were ease of injection, reduction in pain and reduction in injection anxiety.

"One of the key aspects of treating MS is helping patients manage their treatment in order to get the most out of their therapy," said Peter B. Wade, M.D., medical director at the Joyce D. and Andrew J. Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research at Mount Sinai Rehabilitation Hospital in Hartford, Conn. "For many of my patients, AVONEX PEN will help reduce injection-related anxiety and improve the self-injection experience."

The recently-approved AVONEX titration schedule can be facilitated by the AVOSTARTGRIP kit, a set of three devices that work with the AVONEX Prefilled Syringe to administer the appropriate amount of medicine needed to titrate up to a full dose of AVONEX over the course of three weeks. The FDA approved this titration regimen in February 2012, based on data from an eight-week, randomized, healthy volunteer study. It showed that a three-week titration period at treatment initiation reduced the severity of flu-like symptoms associated with AVONEX treatment by 76 percent, as well as significantly reduced the incidence of flu-like symptoms, versus no titration four to six hours post-injection.

Patients who are new to AVONEX treatment have the option to initiate therapy with the AVOSTARTGRIP titration kit; once patients have completed the titration regimen, treatment can be continued with AVONEX PEN or other approved dosing options.