Drug updated on 10/21/2024
| Dosage Form | Suspension (oral; 40 mg/mL) |
| Drug Class | Corticosteroids |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
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Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Vamorolone demonstrated statistically significant improvements in Time to Stand from Supine (TTSTAND) velocity (Mean Difference (MD) = 0.04, 95% Confidence Interval (CI) = 0.02-0.07, p = 0.002), Time to Run/Walk 10 meters (TTRW) velocity compared to placebo (MD = 0.24, 95% CI = 0.11-0.37, p = 0.0003), and Time to Climb 4 Stairs (TTCLIMB) velocity (MD = 0.06, 95% CI = 0.05-0.06, p < 0.00001).
- Vamorolone also showed a statistically significant increase in TTRW velocity compared to glucocorticoids (MD = -0.14, 95% CI = -0.26 to -0.01, p = 0.03) and in height percentile for age (MD = 17.82, 95% CI = 3.89-31.75, p = 0.01).
- The studied population comprised patients with Duchenne muscular dystrophy (DMD), without further specified subgroups.
- There is no safety information available in the reviewed documents.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Agamree (vamorolone) Prescribing Information. | 2024 | Catalyst Pharmaceuticals, Inc., Coral Gables, FL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy of vamorolone in treatment of Duchene muscle dystrophy. A meta-analysis | 2023 | Frontiers in Neurology |