Duchenne muscular dystrophy (DMD) in adults and children aged 5 years or older.
Glucocorticoid; oxazoline derivative of prednisolone. The precise mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown.
0.9 mg/kg/day PO once daily.
Approval was based on a 52-wk study in boys aged 5-15 yr (n=196) with DMD. Deflazacort provided similar improvement in muscle strength compared with prednisone, but with less weight gain.
Griggs RC, et al. Efficacy and safety of deflazacort versus prednisone and placebo for Duchenne muscular dystrophy. Neurology. 2016 Nov 15;87(20):2123-131.
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.