INTERLINK COE Networks & Programs’ Post

Significant Advancement in DMD Treatment by Sarepta Therapeutics! While Pfizer's Phase 3 CIFFREO trial for DMD therapy faced setbacks, last Thursday marked a positive shift with Sarepta's ELEVIDYS label receiving FDA approval, expanding treatment options significantly.  Previously, only DMD boys between aged 4 and 5 were FDA approved to receive the therapy, and now, all young DMD boys and men aged 4 and above will have access per the FDA expansion. In addition, previously, there were strict ambulatory restrictions whereby if the child required assistance with ambulation, they were excluded from having access, whereby, now, this milestone FDA expansion includes full approval for non-wheelchair-dependent patients and accelerated approval for those who are wheelchair-dependent. Despite initial challenges, secondary clinical trial results demonstrating improved motor functions supported this decision, bringing renewed hope to families affected by this devastating disease. We anticipate many DMD boys who were denied access over the past year, may now meet guidelines for access to this potentially life-changing treatment option per the FDA expansion. Symphony Benefit Solutions is staying on top of developing stories like this in the gene and cell therapy arena. We are excited for the 7/1 launch of our fully integrated program, which will tackle high-cost gene and cell therapy treatments while remaining at the forefront of this rapidly changing environment. Reach out to us to learn more about how Symphony Benefits Solution can help at [email protected] This development highlights the continued progress and breakthroughs in the fight against DMD.  #DMD #GeneTherapy #SareptaTherapeutics #FDAApproval #MedicalBreakthrough #SymphonyBenefitSolutions

  • No alternative text description for this image

To view or add a comment, sign in

Explore topics