Topline results from a Phase 3b/4 study, ENGAGE, evaluating Ipsen’s (OTCPK:IPSEY) Dysport (abobotulinumtoxinA) in adult patients with both upper and lower limb spasticity along with a Guided Self-Rehabilitation Contract, showed a treatment benefit. The data are being presented at the MDS International Congress in Nice, France.
The primary endpoint was the proportion of responders at week 6 as measured by a scale called AROM. Specifically, 72.1% (n=98/136) of treated patients were deemed responders. Median time to first response was 47.0 days.
No new safety signals were observed.
The FDA approved Dysport in July 2015 for upper limb spasticity in adults and in June 2017 for adults with lower limb spasticity.
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