On behalf of ITF Therapeutics LLC, we are very pleased to share with you the exciting news that the U.S. Food and Drug Administration (FDA) has approved DUVYZAT™ (givinostat) for the treatment of patients 6 years of age and older with Duchenne muscular dystrophy (DMD). We would like to express our gratitude to all the patients and caregivers around the world who supported this historic research and development effort. This approval would not have been possible without your bravery and dedication. For additional information about the approval of DUVYZAT, please read our press release. You can also access the Full Prescribing Information and other details about DUVYZAT at www.DUVYZAT.com.

The team at ITF Therapeutics is now working to complete all the steps necessary to make DUVYZAT available to appropriate patients in the U.S. We anticipate that there may be questions about the availability of DUVYZAT. To ensure that you have the most up-to-date information you need, including answers to any questions you may have, we will be posting updates on the DUVYZAT website and will also be hosting informational webinars for members of the DMD community in the near future. Updates regarding the schedule for these webinars and how you can take part will be available on the DUVYZAT website. You can also see answers to common questions about DUVYZAT here.

At every stage in the development of DUVYZAT, our team was inspired and encouraged by the many members of the patient and advocacy communities who shared their stories and their hopes for the future. We look forward to continuing our partnership with you to help make a positive difference for patients in the years ahead.

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 DUVYZATis 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 changeyour dose of DUVYZAT if your bloodplatelet counts continueto 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 duringtreatment 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 wateryloose 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 changeyour dose of DUVYZAT if the diarrheacannot be managedor 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 bleedingproblems.

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 medicinesmay 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 causeserious side effects, including:
See “What is the most important information I should know about DUVYZAT?”
changes in the electrical activity of your heart calledQT 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.

Sincerely,
Matt Trudeau
President
ITF Therapeutics

DUV-US-0001 03/2024