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FDA Fast Track for Rare Heart Disease Drug
5 Mar
Summary
- Affinia's AFTX-201 targets BAG3-associated dilated cardiomyopathy.
- AFTX-201 is a one-time intravenous gene therapy for adults.
- The FDA granted fast track designation for potential accelerated approval.
Affinia Therapeutics announced its investigational gene therapy, AFTX-201, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). This designation is for the treatment of BAG3-associated dilated cardiomyopathy (DCM), a rare genetic heart condition.
AFTX-201 is being developed as a one-time intravenous gene therapy for adults diagnosed with BAG3 DCM. The therapy utilizes a novel capsid engineered for cardiac transduction, delivering a BAG3 transgene at significantly lower doses than existing gene therapies.
