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Spinraza Update for Canadian Families - January 24, 2017

Dear Families of SMA Canada Members,

I hope you are doing well.  I would like to update you on the latest information to share about Biogen's Nusinersen application for approval from Health Canada.

There are many questions being asked in terms of where we are with the application from a patient's timeline perspective and what we can do as individuals and a community.

The recent approval of the treatment in the USA has spurred the SMA community here in Canada, with our families requesting immediate access as well.  Canada, however must go through our own review and approval process.  To date, there have been some individuals with a type 1 diagnoses who have been granted special access.  This access is given on an individual basis and is given through Health Canada.  Type 2, 3 and 4 are not given this special access at this time yet.  Biogen understands the high expectations, desires and excitement of Canada's SMA community and have expressed that they are working hard to move the approval process as quickly as possible so all SMA patients can benefit from the medication.

The drug review process is conservative and long, unfortunately. Biogen has a great deal of respect from Health Canada and the community it serves. 

So, what can we do as a community?  Several things can assist the process.

1.      It is important to realize that while it is very difficult to wait patiently, aggressively attacking Health Canada can be counterproductive.  However, letters can be written directly to Health Canada stating why you feel the medication is urgently neededLetters written in an explanatory way, expressing personal feelings can be valuable for understanding our community's need for this approval.

2.      A survey will be sent out soon through FSMAC for your input and experience with SMA.  It is important to note that these surveys must be responded to and in a short period of time.  This survey will be very important for the information it reveals and will have impact.

3.      Share your story, submit photos and stories to help raise awareness of life with SMA.  Share your feelings and your experiences.  I will be compiling them for the purpose of awareness of our community for media, Biogen and Health Canada.  Please send these to fsmacan@telus.net with OUR/MY SMA STORY as your subject.

We are still several months away from hearing a response from Health Canada of their review process of Biogen's submission.  We anxiously await their recommendation for funding.  FSMAC will be submitting a letter on behalf of our community.  In the meantime it is important that we all continue to raise awareness and continue fundraising for our research projects.  We need to keep our momentum going to make change happen for SMA! 

Wishing you all the best,

Susi Vander Wyk
Executive Director
Families of SMA Canada