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23.09.2025 07:17:52
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FDA Grants Fast Track Status To Sanofi's Gene Therapy For Non-Congenital DM1
(RTTNews) - The U.S. Food and Drug Administration has granted Fast Track designation to SAR446268, Sanofi's (SNY,SNYNF,SAN.PA) investigational one-time AAV gene therapy targeting non-congenital forms of myotonic dystrophy type 1 (DM1), including juvenile and adult-onset cases. This designation is intended to accelerate the development and review of therapies that address serious medical conditions and meet unmet treatment needs.
Myotonic dystrophy type 1 (DM1) is a rare, genetic disorder that causes progressive muscle weakness and wasting, with no currently approved medicines.
SAR446268 is currently under investigation in a first-in-human, phase 1-2 study to evaluate the safety, tolerability, and efficacy (clinical study identifier: NCT06844214). The first patient is planned for enrolment in late 2025. Sanofi has already been granted orphan designations for SAR446268 in both the US (July 2024) and European Union.
For More Such Health News, visit rttnews.com.
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