Cure SMA - North Texas Chapter

More treatment progress!

Scholar Rock has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration for apitegromab, an investigational therapy for spinal muscular atrophy.

Scholar Rock anticipates FDA acceptance of the BLA within 30 days of resubmission and a review period of up to six months from the date of resubmission.

Cure SMA will continue to monitor progress and share updates with the community.

Click the link to read the full update: https://www.curesma.org/scholar-rock-resubmits-biologics-license-application-bla-for-apitegromab-to-the-fda/

Incredible news for the SMA Community!

Biogen today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the High Dose regimen of SPINRAZA to treat people living with SMA. With broad label approval for all those living with SMA, this is an excellent result for the SMA community.

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 for those currently receiving treatment, 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 learn more, please visit: https://www.curesma.org/biogen-receives-fda-approval-of-high-dose-spinraza-for-the-treatment-of-sma/