TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport (abobotulinumtoxinA) in five therapeutic indications

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) announced results from new analyses of pivotal Phase III clinical trial data to assess treatment intervals over repeat cycles of DysportA (abobotulinumtoxinA [aboBoNT-A]) in five patient populations. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between 16-17 January 2020 and is organized by the International Neurotoxin Association.1-28 Ipsen is sharing 26 abstracts during the congress, with data including updates from the recently published surveys into the experience of patients and caregivers, data from the Phase IV ULIS-III trial, and ten abstracts focused on basic science research into neurotoxins.1-27

Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilities related to muscle stiffness, including impaired walking and hand use, pain, disfigurement and contractures.29

The new analyses of pivotal Phase III clinical trial data included randomized clinical trials and respective open-label extensions to assess treatment intervals over repeat cycles of DysportA in the management of cervical dystonia (CD), adult lower-limb (ALL) and upper-limb (AUL) spasticity, and pediatric lower-limb (PLL) and upper-limb (PUL) spasticity. Flexible study designs allowed patients to be reinjected after week 12 (or, for PUL, week 16), according to clinical need.1

Results from the five patient populations highlighted that DysportA offered a long duration of response when injected at the recommended and approved dose, with a large proportion of study patients not requiring retreatment for more than 12/16 weeks (% patients injected week-16 or later): in the CD study: 72.6-81.5%, ALL study: 20.1-32.0%, AUL study: 24.0-36.9%, PLL studies: 72.8-93.8%; (% children injected week-22 or later in PUL study: 19.6-67.0%) in the five pivotal studies of DysportA, whilst safety outcomes were as expected.1
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