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Italfarmaco: FDA Submission of New Drug Application for Givinostat

July 4, 2023

Italfarmaco has announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for Givinostat.

Givinostat is the company’s proprietary histone deacetylase (HDAC) inhibitor for the treatment of Duchenne muscular dystrophy. The compound was granted priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) goal date set for December 21, 2023.

“The FDA’s communication on our NDA and the priority review for Givinostat represents a major milestone for Italfarmaco and is a significant step forward in the search for effective treatments against this debilitating rare disease. In our Phase 3 trial, Givinostat demonstrated that it can slow DMD progression, thereby potentially giving young boys and their families a treatment option to retain motor function.

We are excited to be a part of the increasing momentum in this area of medicine with new treatments reaching the market and we hope to achieve a positive impact on the lives of younger and older DMD patients, their families and the medical community that serves them.”

Paolo Bettica, MD, PhD, Chief Medical Officer at Italfarmaco Group

Givinostat clinical trial sites in Canada included Vancouver, Calgary and Toronto and Defeat Duchenne Canada continues to work with Italfarmaco for additional market authorization. Italfarmaco will also be providing additional updates on Givinostat at our Family Forum in Ottawa on November 4-5, 2023.