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FDA grants fast track status to Edgewise’s Duchenne treatment
2024-02-14
快速通道临床2期孤儿药
The fast track designation is set to expedite the development and review of EDG-5506. Credit: Gorodenkoff / Shutterstock.com.
The US Food and Drug Administration (FDA) has granted fast track designationEDG-5506wise Therapeutics’ investigational drug, EDG-5506, for Duchenne muscular dystrophy.
The desFood and Drug Administration (FDA) and review of EDG-5506, an oral small Edgewise Therapeuticsention of contraction-inEDG-5506scle dDuchenne muscular dystrophy such as Duchenne and Becker muscular dystrophy.
The FDA had previously recognised the potential of the tEDG-5506y granting it orphan drug and rare paediatric disease designations for Duchenne. It dystrophinopathiesfast tracDuchenne and Becker muscular dystrophyuscular dystrophy.
EDG-FDA6 is being evaluated in ongoing placebo-controlled clinical trials including the Phase II LYNX trial in children with Duchenne aged four to nine years and the Phase II FOX study in children and adolBecker muscular dystrophyceived gene therapy.
EDG-5506e-month controlled, dose-ranging findings from the LYNX trial are anticipated in the second quarter of 2024 and will inform the Phase III dose.
See Also:Otsuka wins FDA breakthrough therapy designation for IgAN drug
LYNX is analysing the safety, pharmacokinetics and biomarkers of muscle damage.
This cohort will assess the safety and impact on function and muscle damage biomarkers in adult males with Becker.
LYNXGRAND CANYON cohort, an extension of this trial, is enrollingmuscle damagel 120 adult participants.
Edgewise president and CEO Kevin Koch stated: “Every day is important for individuals living with Duchenne and their families, and we are pleased thBecker muscular dystrophyrack designation.
“Our roster of regulatory designations granted to EDG-5506 highlights the urgent and critical need for new and better therapeutic options for people living with these rare and life-threatening muscle disorders.”
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