DUVYZAT resources for you and your practice

DUVYZAT was approved by the US Food and Drug Administration on March 21, 2024.

DUVYZAT is indicated for all patients with DMD 6 years of age and older, regardless of genetic mutation or ambulatory status.^{1* *}The EPIDYS clinical trial did not include nonambulatory patients.

ITF Therapeutics is committed to working with the participants in our clinical trials to ensure they do not experience any lapse in treatment with DUVYZAT. We are coordinating with clinical trial sites to ensure proper support is provided for participants transitioning from the clinical product available in our trials to the commercially available product.

DUVYZAT will be distributed by our exclusive specialty pharmacy provider, PANTHERx^® Rare. PANTHERx specializes in supporting patients with rare diseases. Given the rarity of DMD and the complexity of the reimbursement process, we see important advantages for patients, caregivers, and clinicians in working with a single, high-touch specialty pharmacy to case manage this process and meet the needs of the community.

As a reflection of our commitment to making treatment with DUVYZAT available to as many appropriate patients in the US as possible, we will provide eligible patients with a comprehensive suite of resources through our 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 our patient support services, please visit the patient support page or contact ITF ARC at 1-855-4 ITF ARC (1-855-448-3272).

We are committed to making treatment with DUVYZAT available to as many appropriate patients in the US as possible by working with payers to enable access. We also offer a variety of programs to help patients access treatment while insurers complete their assessments. These include:

• A copay assistance program for commercially insured patients, where patients may pay as little as $0
• A temporary supply program that provides a limited supply of DUVYZAT to help ensure a timely start for appropriate patients facing insurance-related delays
• A bridge program for patients currently on therapy who may be changing insurance providers and might otherwise experience a gap in treatment
• A patient assistance program providing DUVYZAT at no charge for eligible patients, based on established criteria

For more information about our patient support services, please visit the patient support page or contact ITF ARC at 1-855-4 ITF ARC (1-855-448-3272).

We understand that patients may encounter out-of-pocket costs in situations where insurance coverage is insufficient. As a reflection of our commitment to making treatment with DUVYZAT available to as many appropriate patients in the US as possible, we have created a suite of programs to help address potential financial concerns, including:

• A copay assistance program for commercially insured patients, where patients may pay as little as $0
• A temporary supply program that provides a limited supply of DUVYZAT to help ensure a timely start for appropriate patients facing insurance-related delays
• A bridge program for patients currently on therapy who may be changing insurance providers and might otherwise experience a gap in treatment
• A patient assistance program providing DUVYZAT at no charge for eligible patients, based on established criteria

For more information about our patient support services, please visit the patient support page or contact ITF ARC at 1-855-4 ITF ARC (1-855-448-3272).

DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of age and older in the US.¹ DUVYZAT is not approved for patients with Becker muscular dystrophy (BMD). We recognize the significant unmet medical needs of people living with BMD and their families. Our program for BMD is in the early stages of clinical development. It is important to note that this question pertains to an unapproved or uncleared use of DUVYZAT. For further details, please contact Medical Information at medinfo@itftherapeutics.com.

ITF Therapeutics is the US-based rare disease division of Italfarmaco S.p.A. Founded in 1938 in Milan, Italy, Italfarmaco is a private global pharmaceutical company that has led the successful development of many innovative therapeutic products approved for use by patients around the world. The company operates in more than 90 countries on 5 continents and continues to advance promising research to address unmet medical needs in a wide range of therapeutic areas. In January 2024, Italfarmaco launched ITF Therapeutics as a new division in the United States with a focus on the development and commercialization of products to treat rare diseases, including Duchenne muscular dystrophy (DMD). Building on a legacy grounded in collaboration and innovation, ITF Therapeutics strives to partner with leaders from the US patient advocacy and treatment communities to ensure that our programs reflect and support their unique needs and goals. The establishment of ITF Therapeutics also reflects Italfarmaco's goal to build a world-class team of experts who share a passion to make a positive impact for rare disease communities. For more information about ITF Therapeutics, please visit itftherapeutics.com.