FDA Grants Fast Track Designation to SBT101, the First Investigational AAV-Based Gene Therapy for Patients With Adrenomyeloneuropathy (AMN)
Retrieved on:
Wednesday, February 16, 2022
FDA, Health, Genetics, Clinical Trials, General Health, Biotechnology, Hereditary spastic paraplegia, Collection, Patient, Incontinence, AAV, Food, Man, Mass, Review, AMN, VLCFA, Clinical trial, Safety, Adrenoleukodystrophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pain, Mutation, Primate, ALD, FDA, Therapy, Communication, Fast track (FDA), Central nervous system, Disease, Program, Fast Track, Drug development, Pharmaceutical industry, Medical device, ABCD1, SBT101, Adrenomyeloneuropathy, SwanBio Therapeutics, SBT101, ADRENOMYELONEUROPATHY, SWANBIO THERAPEUTICS
AMN is an adult-onset progressive, degenerative spinal cord disease caused by mutations in the ABCD1 gene leading to loss of mobility, incontinence and pain.
Key Points:
- AMN is an adult-onset progressive, degenerative spinal cord disease caused by mutations in the ABCD1 gene leading to loss of mobility, incontinence and pain.
- We look forward to continuing to advance SBT101 as we work toward our goal of bringing life-changing treatments to patients.
- The Fast Track process is designed to facilitate the development and expedite the review of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.
- SwanBio Therapeutics is a gene therapy company that aims to bring life-changing treatments to people with devastating, genetically defined neurological conditions.