Duvyzat FDA Approval History
Last updated by Judith Stewart, BPharm on March 25, 2024.
FDA Approved: Yes (First approved March 21, 2024)
Brand name: Duvyzat
Generic name: givinostat
Dosage form: Oral Suspension
Company: Italfarmaco Group
Treatment for: Duchenne Muscular Dystrophy
Duvyzat (givinostat) is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of age and older.
- Duchenne muscular dystrophy (DMD) is a severe, X-linked neuromuscular disease characterized by progressive muscle degeneration and weakness. It is caused by mutations in the gene that encodes the cytoskeletal protein dystrophin. Dystrophin forms part of the dystrophin-glycoprotein complex that works to strengthen muscle fibers and protect them from injury as muscles contract and relax.
- Duvyzat works in the treatment of DMD by inhibiting histone deacetylases (HDACs), enzymes that prevent gene translation by changing the three-dimensional folding of DNA in the cell. Higher than normal HDAC activity in people with DMD may prevent muscle regeneration and also trigger inflammation. By inhibiting HDACs, Duvyzat slows DMD disease progression, increases muscle mass and reduces muscle tissue necrosis.
- FDA approval of Duvyzat was based on the results of the placebo-controlled phase 3 EPIDYS trial, which met its primary endpoint demonstrating that patients on Duvyzat showed statistically significant and clinically meaningful differences in the time taken to complete the four-stair climb test used to assess motor function of patients with DMD.
- Duvyzat oral suspension is administered twice daily with food.
- Warnings and precautions associated with Duvyzat include hematological changes, increased triglycerides, gastrointestinal disturbances, and QTc prolongation in patients who are at an increased risk for ventricular arrhythmias.
- Common adverse reactions include diarrhea, abdominal pain, thrombocytopenia, nausea/vomiting, hypertriglyceridemia, and pyrexia.
Development timeline for Duvyzat
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
