Highlights:

• First nonsteroidal treatment approved for patients six years of age and older with DMD regardless of genetic mutation now available in the U.S.
• ITF also announces launch of ITF ARC (Access, Resources and Care) patient services program to bring suite of support and educational resources to patients and their families

ITF Therapeutics LLC, the U.S.-based rare disease commercial arm of Italfarmaco, on July 25, 2024, announced the U.S. commercial launch of DUVYZAT™ (givinostat), a histone deacetylase inhibitor, for the treatment of patients six years of age and older with Duchenne muscular dystrophy (DMD). DUVYZAT was approved by the U.S. Food and Drug Administration (FDA) on March 21, 2024.

“We also express our gratitude to the individuals living with DMD who participated in our clinical trials, their families, DMD advocacy leaders, and the healthcare professionals who have all played a central role in helping us make DUVYZAT available to the DMD community.”

Matt Trudeau, President, ITF Therapeutics

About Duvyzat™

DUVYZAT is a U.S. FDA approved therapy indicated for the treatment of patients six years of age and older with Duchenne muscular dystrophy (DMD) that was discovered through the research and development efforts of Italfarmaco in collaboration with Telethon and Duchenne Parent Project (Italy). DUVYZAT is a histone deacetylase (HDAC) inhibitor that modulates the deregulated activity of HDACs in the dystrophic muscle, which is a major consequence of the lack of dystrophin associated with DMD. Though the exact mechanism of action of DUVYZAT is unknown, it is believed to inhibit HDAC pathological overactivity to address the cascade of events leading to muscle damage, thereby counteracting the disease pathology and slowing down muscle deterioration.