Biogen today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the High Dose regimen of SPINRAZA (nusinersen) to treat people living with spinal muscular atrophy (SMA). With broad label approval for all those living with SMA, this is an excellent result for the SMA community.
SPINRAZA (nusinersen) is an antisense oligonucleotide therapy that works by increasing production of survival motor neuron (SMN) protein, which is critical for motor neuron function. The High Dose regimen is designed to further enhance SMN protein levels.
This FDA approval marks another important step forward in the ongoing effort to treat and manage SMA. The High Dose regimen of SPINRAZA has the potential to provide additional benefit, offering new possibilities for improved outcomes and quality of life. Cure SMA is committed to working closely with Biogen, healthcare providers, and the SMA community to support timely education and access to this new dosing option, in alignment with its approved use.
To view Biogen's latest community statement on this approval, click here.
Cure SMA and Biogen to Host Community Webinar
Please join us for a community webinar on the recent FDA approval of the High Dose regimen of SPINRAZA (nusinersen).
Date: Thursday, April 30
Time: 11:00am CT / 12:00pm ET
This live session will share the latest information about the approval and what it means for individuals and families impacted by SMA. A moderated Q&A will follow, featuring questions submitted in advance.
Register here: https://us02web.zoom.us/webinar/register/WN_SGLi86_fTVeP1ZtmjaISww
This webinar is intended for U.S. audiences only.
Thank You!
Cure SMA extends our heartfelt gratitude to individuals and families impacted by SMA, as well as the donors, advocates, and researchers who helped make this milestone possible. From early research investments to participation in clinical trials that generated the data supporting this approval, your contributions have been critical to advancing treatment. We thank our partners at Biogen for their continued commitment to the SMA community and their efforts to expand treatment options. We also extend our gratitude to the FDA for their ongoing partnership and attention to the unmet needs of the SMA community.
If you have questions or need support understanding what this approval means for you or your loved one, please contact us at: [email protected].