Dear colleagues,

We are very pleased to share with you the exciting news that DUVYZAT™ (givinostat) is now commercially available in the U.S. for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. To learn more about the commercial launch of DUVYZAT, please click here to see our press release.

Throughout the development of DUVYZAT we heard from so many families and members of the advocacy community about the critical need for new treatment options for DMD. As an HDAC inhibitor, DUVYZAT is a nonsteroidal therapy approved for the treatment of DMD and may be an option for appropriate patients regardless of their genetic mutation. The efficacy and safety of DUVYZAT were evaluated in the pivotal Phase 3 EPIDYS clinical trial, which was one of the largest Phase 3 clinical studies in DMD to date.

Over the past several months the entire ITF Therapeutics team has worked closely with many members of the DMD advocacy community to bring this new treatment option to patients as rapidly as possible. We are very grateful to you and to all the advocates, families, and clinicians who supported this effort. Patients and caregivers can now reach out to their healthcare providers to learn more about how to access treatment with DUVYZAT. To initiate treatment for eligible patients, healthcare providers must complete the Patient Start Form that is available on our dedicated website www.DUVYZAT.com. In addition to initiating the prescription fulfillment process, patients can also enroll in ITF ARC (Access, Resources and Care), the portfolio of patient support services available from ITF Therapeutics. Through ITF ARC, patients and caregivers can access services to help them navigate through insurance challenges, personalized pharmacist support, financial and access assistance for eligible patients, educational materials, and other resources. For more information about ITF ARC, please visit www.DUVYZAT.com/ITFARC.

The commercial launch of DUVYZAT represents a historic milestone in the treatment of DMD. It also reinforces our goal to be an effective partner and resource for all members of the advocacy community who are dedicated to improving care for patients. In the months ahead we will work to keep you updated on important news related to DUVYZAT. You can also reach out to us any time for any information you need. For general inquiries, contact us at [email protected], or reach out to Caroline Allen, Head of US Patient Advocacy and Communications, directly at [email protected].

Thank you for your interest in DUVYZAT.

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.

Sincerely,
Matt Trudeau
President, ITF Therapeutics

C-DUV-US-0003 07/2024