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Italfarmaco: Receives EMA Validation of Marketing Authorization Application for Givinostat

September 5, 2023

Italfarmaco Group has announced that its Marketing Authorization Application (MAA) for Givinostat as a potential treatment for Duchenne muscular dystrophy (DMD) has been submitted to the European Medicine Agency (EMA) and that the EMA has started its regulatory review process.

The acceptance of their submissions to European and U.S. regulatory bodies reflects Italfarmaco’s research efforts and commitment to the successful clinical development of Givinostat and brings hope for Canadians for submission to Health Canada.

“The Phase 3 evaluation of Givinostat demonstrated that it can slow DMD progression in boys six years and older. If approved, Givinostat could greatly benefit younger and older DMD patients by preserving their motor skills and muscle strength. Now that our market authorization application is under review, we are looking forward to working with the regulatory authorities to bring this treatment option to patients affected by this devastating disease with the goal of providing therapeutic benefit and increasing their quality of life.”

Paolo Bettica, MD, PhD, Chief Medical Officer

Italfarmaco Group’s New Drug Application (NDA) submission for Givinostat to the U.S. Food and Drug Administration (FDA) was granted priority review for Givinostat as announced in June this year.

The Phase 3 clinical trial, EPIDYS, evaluated the efficacy and safety of Givinostat in 179 ambulant DMD patients six years and older, including three trial sites in Canada:

  • Kinsmen Research Centre – Alberta Children’s Hospital – Alberta Health Services (Calgary, Alberta)
  • The University of British Columbia, Children’s and Women’s Health Centre of BC Branch (Vancouver, British Columbia)
  • Holland Bloorview Kids Rehabilitation Hospital (Toronto, Ontario)