givinostat (Duvyzat)

From Aaushi
Jump to navigation Jump to search

Indications

Dosage

  • 10 mg/mL PO BID (dose flexible, based on weight)
  • reduce dose if not tolerated

Mechanism of action

More general terms

References

  1. FDA NEWS RELEASE. March 21, 2024 FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy https://www.fda.gov/news-events/press-announcements/fda-approves-nonsteroidal-treatment-duchenne-muscular-dystrophy
  2. Shaw ML Givinostat Receives Full FDA Approval for Duchenne Muscular Dystrophy American Journal of Managed Care (AJMC). 2024. March 21. https://www.ajmc.com/view/givinostat-receives-full-fda-approval-for-duchenne-muscular-dystrophy
  3. Mercuri E, Vilchez JJ, Boespflug-Tanguy O et al Safety and efficacy of givinostat in boys with Duchenne muscular dystrophy (EPIDYS): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2024 Apr;23(4):393-403. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38508835 Clinical Trial. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00036-X/fulltext