May 4, 2017
In response to your request for information, we would like to inform you that recently the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a marketing authorization in the European Union for SPINRAZA (nusinersen) to treat patients with spinal muscular atrophy (SMA).
Nusinersen is the first SMA treatment recommended by CHMP for approval in the European Union (EU).
The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the EU. A decision from the EC is expected within the next few months. The final decision will be applicable to all 28 EU member countries plus Iceland, Norway and Liechtenstein.
In Canada, Health Canada continues to review the application from Biogen Canada and as previously communicated we anticipate a decision by mid-year 2017.
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.
We remain committed to transparent and timely communications and will continue to be available to provide any requested updates.
For further questions, please contact Biogen Canada Inc
Medical Information at: 1-866-477-3462