June 4, 2017
Dear members of the SMA community, In response to your request for information, we are delighted to inform you that on June 1 2017 Biogen announced that the European Commission (EC) granted a marketing authorization for SPINRAZA® (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA) which is the most common form of the disease and represents approximately 95% of all SMA cases. Nusinersen, the first approved treatment in the European Union (EU) for SMA, was reviewed under the European Medicine Agency’s accelerated assessment program, intended to expedite access to patients with unmet medical needs.
In Canada, we anticipate a response regarding marketing authorization from Health Canada mid-year 2017. Obtaining regulatory approval across the globe and in Canada has remained our number one priority, as we believe it is the best route to long-term sustainable access to nusinersen for the greater SMA community. We continue to work with Health Canada to conclude our discussions.
At the time of Health Canada approval, the steps to achieve reimbursement will progress according to Canadian-specific requirements. Biogen Canada will continue to work with agencies and provincial governments through the required processes of review and approval so that Canadians with SMA can have access to nusinersen. A more detailed outline of this process and usual timelines in Canada can be found on the Cure SMA Canada website
http://curesma.ca/pdf/research2017/cdn-drug-approval-process-fchart2017.pdf Thank you for the support we consistently receive from the entire SMA community. We would not have reached this historic moment without you and your families, the physicians and researchers who have supported the nusinersen program. This important milestone in the EU brings new hope to patients, families and the SMA community and reflects our commitment to improving the lives of patients with serious neurological diseases.
Our commitment to the SMA community remains steadfast. We still have much work to do and we will continue to work tirelessly to ensure that patients who may benefit from nusinersen will be able to access nusinersen as quickly as possible in Canada
Biogen For further questions,
please contact Biogen Canada Inc Medical Information at: 1-866-477-3462
June 4, 2017