next steps following Health Canada’s approval of SPINRAZA™ (nusinersen).
Dear members of the SMA community, In response to your request for information, we would like to provide you with an update on Biogen’s SMA360 Canada Patient Support Program and the next steps following Health Canada’s approval of SPINRAZA™ (nusinersen). The SMA360 Canada Patient Support Program has been developed to be available for patients and…
We have completed our submission in to CADTH!
We have completed our submission in to CADTH! Thanks to everyone’s support and heartfelt responses, we feel we have a very strong message to the drug review committee expressing the needs of the entire SMA committee for effective treatment and the benefits of Spinraza to improve the lives of all persons and families affected by…
Approval of nusinersen/spinraza from Health Canada
Cure SMA Canada is very happy to announce the approval of nusinersen/spinraza from Health Canada. We are very excited to confirm the approval for treatment for all types of SMA in Canada. We will be communicating with the Canadian sma community our next steps as we move forth into the funding approval process to CADTH’s…
European Commission (EC) granted a marketing authorization for SPINRAZA®
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…
Nusinersen is the first SMA treatment recommended by CHMP for approval in the European Union
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…
Biogen updates Special Access Program (SAP) through Health Canada.
May 4, 2017 Dear members of the SMA community, In response to your request for information, we would like to provide you with an update on Biogen’s global Expanded Access Program (EAP), called the Special Access Program (SAP) through Health Canada. Based on the high unmet need in SMA, and to bridge the gap between…
Progress being made in Europe and Canada to obtain regulatory approval for nusinersen
Dear members of the SMA community, In response to your request for ongoing information, we are providing you with additional updates. The main points in this update include: • the progress being made in Europe and Canada to obtain regulatory approval for nusinersen, • clarification around recent news about the U.S. price that was released…
