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Journal Article
Givinostat: First Approval
2024
Overview
Givinostat (DUVYZAT™), an orally available histone deacetylase inhibitor, is being developed by Italfarmaco for the treatment of muscular dystrophy and polycythemia vera. Givinostat received its first approval on 21 March 2024, in the USA, for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. Approval was based on the results of the multinational phase III EPIDYS trial, in which givinostat recipients showed less decline than placebo recipients in the time taken to perform a functional task. Givinostat represents the first nonsteroidal treatment for DMD to be approved for use in patients irrespective of the specific genetic variant underlying their disease. Givinostat is available as an oral suspension to be administered twice daily with food. The recommended dosage is based on the body weight of the patient. In the EU, regulatory review of givinostat in DMD is currently underway. This article summarizes the milestones in the development of givinostat leading to this first approval for DMD.
Publisher
Springer International Publishing,Springer Nature B.V
Subject
/ Carbamates - administration & dosage
/ Carbamates - therapeutic use
/ Child
/ Disease
/ Duchenne's muscular dystrophy
/ Histone Deacetylase Inhibitors - administration & dosage
/ Histone Deacetylase Inhibitors - adverse effects
/ Histone Deacetylase Inhibitors - pharmacology
/ Histone Deacetylase Inhibitors - therapeutic use
/ Humans
/ Medicine
/ Muscular Dystrophy, Duchenne - drug therapy
/ Proteins
/ Steroids
