On June 18, 2024, ITF Therapeutics shared an update on the commercial availability of DUVYZAT (ginovostat) for the treatment of Duchenne muscular dystrophy.
Please continue reading for ITF Therapeutics’ full update.
In March of this year DUVYZAT was approved by the U.S. Food and Drug Administration for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. This historic approval would not have been possible without the support and engagement of many members of the DMD community.
We are pleased to share with you an update on the efforts by ITF Therapeutics LLC to complete all the necessary planning and regulatory filings to make DUVYZAT fully available to patients as rapidly as possible. At this stage, we remain on track to complete all the necessary state regulatory filings and other requirements so that DUVYZAT can become commercially available to appropriate patients in the U.S. during the third quarter of this year.
We have also created a comprehensive suite of patient education and support resources specifically for members of the DMD community through our new patient services program, ITF ARC. This includes support to help patients and families navigate through insurance challenges, personalized pharmacist support, financial assistance for eligible patients, educational materials, and other resources. For more information about ITF ARC, please visit www.DUVYZAT.com. =
As we work to complete the final steps in the commercialization process, we will continue to keep you updated on our progress. Please visit www.DUVYZAT.com for the latest information and updates about the commercial availability of DUVYZAT. In addition, we will be sharing details about upcoming community webinars on the DUVYZAT website in the coming weeks. You can also reach out to Caroline Allen, U.S. Patient Advocacy and Communications Lead, directly at [email protected].
Indication and Important Safety Information
What is DUVYZAT?
DUVYZAT is a prescription medicine that is used for the treatment of Duchenne muscular dystrophy (DMD) in people 6 years of age and older.
It is not known if DUVYZAT is safe and effective in children under 6 years of age.
Important Safety Information
What is the most important information I should know about DUVYZAT?
- Low platelet counts in your blood (thrombocytopenia). Platelets are important for blood clotting, and a decrease in their numbers can lead to an increased risk of bleeding or bruising. Your healthcare provider will check your blood count before you start DUVYZAT and regularly during treatment for any signs of thrombocytopenia. Call your healthcare provider right away if you notice any unusual bleeding or small red or purple spots on the skin called petechiae. Your healthcare provider may change your dose of DUVYZAT if your blood platelet counts continue to be low or may stop your treatment with DUVYZAT.
- Increased levels of fat (triglycerides) in your blood. You may not have any symptoms, so your healthcare provider will do blood tests before you start DUVYZAT and regularly during treatment to check your triglyceride levels. Your healthcare provider may change your dose of DUVYZAT if your triglyceride levels continue to be high or may stop your treatment with DUVYZAT.
- Frequent watery loose stools (diarrhea) and vomiting. DUVYZAT can cause vomiting and moderate to severe diarrhea. If diarrhea occurs, you should keep track of the frequency and severity of your diarrhea symptoms, drink plenty of fluids, and contact your healthcare provider. Your healthcare provider may change your dose of DUVYZAT if the diarrhea cannot be managed or does not go away. Your healthcare provider may also stop your treatment with DUVYZAT.
Before taking DUVYZAT, tell your healthcare provider about all of your medical conditions, including if you:
- have any heart problems or if you take any medicines that could increase your chance for irregular heart rhythms.
- have any bleeding problems.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking DUVYZAT with certain other medicines may affect each other. Taking DUVYZAT with other medicines can cause serious side effects. Do not start or stop other medicines without talking to your healthcare provider.
DUVYZAT can cause serious side effects, including:
- See “What is the most important information I should know about DUVYZAT?”
- changes in the electrical activity of your heart called QT Prolongation. QT Prolongation can increase the risk of developing a type of irregular heart rhythm known as Torsades de Pointes. Call your healthcare provider right away if you feel faint, have an irregular heartbeat, feel dizzy, or lose consciousness.
The most common side effects of DUVYZAT included diarrhea, nausea, vomiting, stomach pain, low platelet counts in the blood, increased fat level in the blood and fever.
These are not all of the possible side effects of DUVYZAT. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
Please see full Prescribing Information and Medication Guide.
DUVYZAT is a registered trademark of Italfarmaco S.p.A.
