Italfarmaco Receives FDA Approval for Duvyzat™ (givinostat) in Duchenne Muscular Dystrophy
Retrieved on:
Friday, March 22, 2024
Research, FDA, Genetics, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, HDAC, ITF, MAA, The Lancet, Caregiver, Disease, Magnetic resonance imaging, PPMD, Patient, Rehabilitation, Lancet Neurology, University, EMA, Doctor of Philosophy, MD, Duchenne muscular dystrophy, Pediatrics, Therapy, NSAA, DMD, Food, Pharmaceutical industry
“We are grateful for the support of those living with DMD and their dedicated caregivers, which played a central role in helping us reach this landmark FDA approval.
Key Points:
- “We are grateful for the support of those living with DMD and their dedicated caregivers, which played a central role in helping us reach this landmark FDA approval.
- The FDA approval highlights the dedication of Italfarmaco’s research and clinical teams to achieve this milestone for the company.”
The approval is based on the results of the pivotal multicentre, randomised, double-blind, placebo-controlled phase 3 EPIDYS trial ( NCT02851797 ). - Italfarmaco has significantly expanded its U.S. presence through the formation of a new fully owned subsidiary, ITF Therapeutics LLC.
- Italfarmaco has a global presence and is also working with other regulatory agencies.