Biogen announces the Health Canada is reviewing Spinraza – Jan 5, 2017.
For late breaking details about Spinraza, check the Cure SMA (US) research news page and the Spinraza page, though some information may be only applicable for US treatment.
The expanded access program lists Montreal and London, ON as treatment sites, and hopefully more will be added soon.
January 5 2017
Dear Members of the SMA Community,
In response to your requests for ongoing information, we are providing an update on the
progress made in moving the nusinersen development program forward.
On December 12 2016, we received confirmation from Health Canada that nusinersen has been accepted
for review.
While regulatory review times vary, our current understanding is that the review may take 6-7 months to
complete. We are providing all the data we have to date and are seeking a broad label for the
treatment of SMA. Health Canada reviews the totality of the data provided, and if approved,
the content and breadth of the final label is decided by them based on their assessment of the
data we provide to them. The product label will instruct physicians on the use of nusinersen, if
approved.
In addition, we continue to be encouraged by the data from a number of nusinersen studies
recently presented in late-breaking session at the 2016 World Muscle Society Congress in
Granada, Spain.
We appreciate the questions we have received from the SMA community over the past several
weeks and are pleased to share this progress for the nusinersen program. Please know we
understand every day counts for patients with SMA and their families. Each member of our
team is working tirelessly and exploring every option to speed the development, and hopefully,
approval of nusinersen.
For further questions, please contact Biogen Canada Inc
Medical Information at: 1-866-477-3462
Sincerely,
Biogen Canada Inc.
