Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Biogen Idec is committed to improving the lives of people with multiple sclerosis (MS), and no company is doing more for these patients. There has been a desire within the MS community for an oral treatment for a long time, and the approval of Gilenya has made this a reality.

MS impacts each person differently and, until we have a cure, there should be multiple treatments available to address the individual needs of patients. Today, Biogen Idec is pleased to provide leading MS therapies AVONEX^® (interferon beta-1a) and TYSABRI^® (natalizumab), both of which have been used in a broad range of patients worldwide.

Biogen Idec also has the most robust pipeline in the industry, with three late-stage clinical candidates that target multiple pathways thought to be critical in treating MS. BG-12, our Phase 3 investigational oral therapy, has demonstrated promising safety and efficacy data in clinical studies, which supported its further investigation. Prior clinical evidence suggests that BG-12 may have the potential to both reduce inflammation and promote neuroprotection. We look forward to seeing the Phase 3 data in 2011.

As with any treatment, patients and physicians should consider not only efficacy, but safety, tolerability and long-term experience when choosing a treatment option. The long-term safety profile of Gilenya has yet to be established and there is limited data for it in patients with certain common comorbidities. We agree with the FDA that there is a need for safety monitoring for Gilenya through a comprehensive Risk Evaluation and Mitigation Strategy (REMS). As we enter an era where new therapies may have important safety concerns, we believe it is the responsibility of all companies bringing MS drugs to market to be rigorous in monitoring for these issues.