Italfarmaco, the company that developed DUVYZAT® (givinostat), has shared a letter to the Duchenne muscular dystrophy community addressing concerns raised in recent online, community-based discussions about patient deaths involving individuals living with Duchenne who were being treated with DUVYZAT. DUVYZAT was approved by the U.S. Food and Drug Administration (FDA) in March 2024 for individuals 6 years and older living with Duchenne.
Italfarmaco stated that DUVYZAT’s safety profile remains unchanged and that all relevant data and assessments have been submitted to regulatory agencies. Should this assessment change, the company has committed to promptly communicating updates to regulators, healthcare professionals, and the Duchenne community.
DUVYZAT remains available and approved for use in the U.S. PPMD encourages families to contact their neuromuscular providers with any questions about ongoing treatment or safety monitoring.
Read Italfarmaco’s letter to the community:
Dear DMD Community,
As you may be aware, there have been recent online discussions about patient deaths involving individuals living with Duchenne muscular dystrophy (DMD) who were being treated with DUVYZAT® (givinostat). We remain deeply saddened to learn that these individuals have passed away.
Based on all available information, and applying internationally recognised standards, Italfarmaco has assessed these deaths are not related to treatment with DUVYZAT, and the product’s benefit-to- risk profile remains unchanged. All relevant data and assessments have been submitted to regulatory authorities. Should this assessment change, we will promptly communicate updates to regulatory authorities, healthcare professionals, and the DMD community, as part of the standard process for ensuring patient safety and transparency.
At Italfarmaco, our commitment to patient safety is a top priority. We understand how concerning any patient adverse event may be for families and healthcare providers. To date, nearly 2,000 patients living with DMD have been treated with givinostat (DUVYZAT), with some receiving therapy for over 10 years. All serious adverse events reported to Italfarmaco are reported to health authorities in accordance with regulatory requirements, and we work in collaboration with regulatory authorities around the world to assess data.
We will continue to closely monitor, investigate, and report data to ensure we maintain a deep understanding of the safety profile of DUVYZAT. We are grateful for the trust of the DMD community and acknowledge that we need to earn that trust every day.
Sincerely,
Scott Baver
Vice President Head of Medical Affairs, Italfarmaco
Paolo Bettica
Chief Medical Officer, Italfarmaco
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