"On behalf of everyone at Biogen Idec and Elan, I want to thank the many people living with MS, their caregivers, physicians and others for expressing your thoughts and opinions on TYSABRI® (natalizumab) over the last several months. In particular, at the FDA Advisory Committee meeting in March, dozens of patients and physicians spoke eloquently about the unmet medical need in multiple sclerosis and the need for new therapeutic options like TYSABRI. It took a great deal of courage to share their voice, and in the end, it helped inform the process for reintroducing TYSABRI in the US, and also helped advance a better understanding that MS is a serious and often debilitating disease.
The unanimous recommendation from the FDA Advisory Committee was an important step forward in our efforts to bring TYSABRI back. The FDA has stated that it needs more time to review the TYSABRI Risk Management Plan, and we now expect to hear back from the Agency on or before June 28.
The Risk Management Plan (RiskMAP) is an important component of the reintroduction of TYSABRI and we want to make sure that it is implemented appropriately and is understood and operationalized by healthcare professionals and patients. The RiskMAP is designed to facilitate informed risk-benefit conversations between physicians and patients, minimize the risk of progressive multifocal leukoencephalopathy (PML) and assess the incidence and risk factors associated with TYSABRI. We continue to work diligently with the FDA to finalize the details of this.
We hope to offer people living with MS the option to choose this therapy once again. Thank you again for your patience and inspiration during this time.
Sincerely,
James C. Mullen
President and CEO
Biogen Idec"
