Profile
General Information
Duvyzat (givinostat) is a histone deacetylase inhibitor.
Duvyzat is specifically indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
Dosing/Administration
Duvyzat is supplied as an oral suspension.
Recommended Evaluation and Testing Before Initiation of Duvyzat
- Obtain and evaluate baseline platelet counts and triglycerides prior to initiation of Duvyzat. Do not initiate Duvyzat in patients with a platelet count less than 150 x 109/L. Monitor platelet counts and triglycerides as recommended during treatment to determine if dosage modifications are needed.
- In patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs when initiating treatment with DUVYZAT, during concomitant use, and as clinically indicated
The recommended dosage of Duvyzat is based on body weight and administered orally twice daily with food.
Weight | Dosage | Oral Suspension Volume |
10 kg to less than 20 kg | 22.2 mg twice daily | 2.5 mL twice daily |
20 kg to less than 40 kg | 31 mg twice daily | 3.5 mL twice daily |
40 kg to less than 60 kg | 44.3 mg twice daily | 5 mL twice daily |
60 kg or more | 53.2 mg twice daily | 6 mL twice daily |
Mechanism of Action
Duvyzat (givinostat) is a histone deacetylase inhibitor. The precise mechanism by which Duvyzat exerts its effect in patients with DMD is unknown.
Side Effects
Adverse effects associated with the use of Duvyzat may include, but are not limited to, the following:
- diarrhea
- abdominal pain
- thrombocytopenia
- nausea/vomiting
- hypertriglyceridemia
- pyrexia
Clinical Trial Results
FDA approval of Duvyzat was based on the results of the pivotal multicentre, randomised, double-blind, placebo-controlled phase 3 EPIDYS trial. In the EPIDYS study, a total of 179 ambulant boys six years of age or older received either Duvyzat twice daily or placebo, in addition to glucocorticosteroid treatment. The EPIDYS study met its primary endpoint demonstrating that patients on Duvyzat showed a statistically significant and clinically meaningful difference in time to complete the four-stair climb assessment. Duvyzat also showed favourable results on key secondary endpoints including North Star Ambulatory Assessment (NSAA), and fat infiltration evaluation by magnetic resonance imaging.
Duvyzat also showed favorable outcomes in key secondary measures, including on the North Star Ambulatory Assessment (NSAA), a 17-item scale that measures motor function skills. On the NSAA, patients treated with the new drug saw less worsening compared to placebo after 18 months.