vyondys 53
vyondys 53: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.
vyondys 53 evidence translation
What we can confirm
1 FDA record · 1 tracked trial
What it means
What to watch
Prepared research question
How could vyondys 53 → SRPT affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (1)
| Company | Phase |
|---|---|
| Sarepta Therapeutics, Inc. (SRPT) | Approved |
Clinical Trials (1)
A 48-Week, Open Label, Study to Evaluate the Efficacy and Safety of AMONDYS 45, EXONDYS 51, VYONDYS 53 in Subjects With DuchenneMuscular Dystrophy Carrying Eligible DMD Duplications.
Primary endpoint: Change in Dystrophin Expression From Baseline Following Treatment With Either AMONDYS 45 (Previously Casimersen), EXONDYS 51 (Previously Eteplirsen ), or VYONDYS 53 (Previously Golodirsen)
FDA Decisions1 records
Frequently asked questions
Who is developing vyondys 53?
vyondys 53 is being developed by Sarepta Therapeutics, Inc..
How many clinical trials involve vyondys 53?
BioSniper tracks 1 clinical trial involving vyondys 53.
What is vyondys 53's latest FDA decision?
The most recent tracked FDA decision for vyondys 53 is Approval for 1 INDICATIONS AND USAGE VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53 [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification of a clinical benefit in conf, dated December 12, 2019.