Biogen Idec announces new easier to use injection for multiple sclerosis

By Dr. Ananya Mandal, MDFeb 29 2012

According to Drugmaker Biogen Idec this Tuesday, it has received U.S. approval for an easier-to-use form of its multiple sclerosis injection Avonex.

The Food and Drug Administration approved the company's Avonex pen, an injection designed to reduce pain and anxiety when patients self-administer the drug. The FDA also approved a new dosing schedule for the drug intended to reduce flu-like symptoms often associated with the drug.

At present Biogen offers a program in which registered nurses visit Avonex patients and teach them to self-inject the original form of Avonex. The drug was approved in 1996.

Biogen in another announcement said it submitted an FDA application for an experimental multiple sclerosis pill known as BG-12 (dimethyl fumarate). The application consists of two company studies showing reduction in disease activity and favorable safety and tolerability, according to the Cambridge, Mass.-based company. The regulatory submission was based on BG-12’s comprehensive development program, in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase 3 DEFINE and CONFIRM studies.

“While there have been important therapeutic advances in MS over the last 15 years, there is still a significant unmet need for new and innovative therapies that target the disease in different ways,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “Based on the robust clinical efficacy and safety data seen in our Phase 3 studies, we believe BG-12 has the potential to become an important oral treatment option for MS patients.”

“The rapid submissions of our BG-12 regulatory packages, which integrated one of the largest placebo-controlled data sets for a filing in MS, reflect our commitment to bringing additional therapies to patients in need as quickly as possible,” concluded Dr. Williams. “We anticipate hearing from regulatory authorities regarding the status and acceptance of our submissions within the next couple of months.”

Biogen also markets the multiple sclerosis drug Tysabri with Elan Pharmaceuticals Inc.

Multiple sclerosis is a disease of the immune system in which the body attacks the brain and spinal cord.