The FDA grants Fast Track designation to SAR446268, Sanofi’s gene therapy for non-congenital forms of myotonic dystrophy type 1, a rare genetic disorder causing muscle weakness. The therapy is currently in a phase 1-2 study, with the first patient planned for enrollment in late 2025. Sanofi has orphan designations for SAR446268 in the US and EU. This designation aims to accelerate the development of therapies for serious medical conditions with unmet treatment needs. No approved medicines currently exist for myotonic dystrophy type 1. For more health news, visit rttnews.com.

Read more at Nasdaq: FDA Grants Fast Track Status To Sanofi’s Gene Therapy For Non-Congenital DM1