Emflaza (deflazacort)
Indication:
Duchenne muscular dystrophy (DMD) in adults and children aged 5 years or older.
Mechanism:
Glucocorticoid; oxazoline derivative of prednisolone. The precise mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown.
Dosage:
0.9 mg/kg/day PO once daily.
Approval:
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.
Reference:
Medscape © 2018 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.
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