Date: 2017-06-16
Type of information: Granting of a Market Authorisation in the US
Product name: Dysport® (abobotulinumtoxin A)
Compound: abobotulinumtoxin A
Therapeutic area: Neurological diseases - CNS diseases
Action mechanism:
- protein. Dysport® is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium BoNT-A bacteria. It is supplied as a lyophilized powder. Dysport® was first registered for the treatment of blepharospasm and hemifacial spasm in the UK in 1990, and is licensed in more than 75 countries for various indications including: blepharospasm, adult upper and lower limb spasticity, hemifacial spasm, spasmodic torticollis (ST) (previously referred to as cervical dystonia), pediatric lower limb spasticity due to cerebral palsy (CP), axillary hyperhidrosis, and glabellar lines.
Company: Ipsen (France)
Disease: upper limb spasticity, pediatric patients with lower limb spasticity, spasticity in adults
Latest news:
- • On June 16, 2017, Ipsen announced that the FDA has expanded the approved use of Dysport® (abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based on its supplemental
Biologics License Application (sBLA) in lower limb spasticity. In July 2016, Dysport® was approved to treat
pediatric patients with lower limb spasticity aged two and older, making it the first and only botulinum
toxin that the FDA approved for this indication.
In a Phase III, multi-center, prospective, double-blind, randomized placebo-controlled study, adult patients treated with Dysport® following a stroke or traumatic brain injury showed improvement in muscle tone at the ankle joint, measured by the mean change from baseline on the Modified Ashworth Scale (MAS) at Week 4. The duration of response for the majority of patients within the study was between 12 16 weeks. In this study, some patients experienced a longer duration of response (approximately 20 weeks). The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of Dysport® and muscles to be injected. Repeat Dysport® treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection.
- • On July 16, 2015, Ipsen announced that the FDA has approved its supplemental Biologics License Application (sBLA) for Dysport®v(abobotulinumtoxinA) for the treatment of upper limb spasticity in adult patients after the submission of the dossier in September 2014. Dysport® is now approved for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors. Clinical improvement may be expected one week after administration of Dysport®. A majority of patients in clinical studies were retreated between 12 and 16 weeks; some patients had a duration of response as long as 20 weeks. In Europe, regulatory procedures are in progress for strengthening the existing upper limb spasticity label indication of Dysport® to include key medical data such as muscle dose recommendations, treatment intervals, efficacy data and safety updates.
The approval was based on a rigorous development program that included clinical trials conducted in over 600 patients. In the Phase III pivotal study, 238 adult patients with upper limb spasticity participated in the study for up to one year. The international, multi-center, double-blind, randomized, placebo-controlled study compared the efficacy of Dysport® (n=159) versus placebo (n=79) in hemiparetic patients following stroke or brain trauma. The trial also included patients who were botulinum toxin naïve or previously treated with a botulinum toxin, encompassing a broad patient population. The co-primary endpoints of the study were the improvement of muscle tone in the treated upper limb measured by the Modified Ashworth Scale (MAS) versus placebo and the clinical benefit for patients as assessed by the Physician Global Assessment (PGA) versus placebo at Week 4. The trial was followed by an open-label study wherein patients received Dysport® for up to five treatment cycles to assess the long term safety.
The Phase III pivotal data showed that those treated with Dysport® demonstrated statistically significant improvement in muscle tone measured by the MAS and a significantly higher physician-rated clinical benefit measured by the PGA versus placebo at Week 4 (p? 0.05). At Week 4, both doses of Dysport® (Dysport® 500 units and 1000 units) significantly reduced muscle tone as measured by MAS in all primary target muscle groups, which included elbow, wrist, and finger muscles, with approximately 3 out of 4 patients responding to Dysport®. The most frequently reported adverse reactions (?2%) are: urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, fall and depression. The safety profile observed in the study was consistent with the known safety profile of Dysport®, and there were no differences in the rate of serious adverse events between the treatment groups: placebo (3.7%), Dysport® 500 U (3.7%), Dysport® 1000 U (3.7%).
- • On November 28, 2014, Ipsen announced that the FDA has accepted for review its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) in the treatment of upper limb spasticity in adult patients. The regulatory filing was based on a clinical Phase III study involving nearly 250 adult patients with upper limb spasticity. The international, multi-center, double-blind, randomized, placebocontrolled trial compared the efficacy of Dysport® versus placebo in hemiparetic patients following a stroke or brain trauma. The data showed that those treated with Dysport® demonstrated a statistically significant (p<0.0001) improvement in muscle tone and a higher clinical benefit, versus placebo. The safety profile observed in the study was consistent with the known safety profile of Dysport®. This phase III research study included was conducted in the USA, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary.
Patents:
Submission of marketing authorization application USA : 2014-09-00
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2015-07-16/2017-06-16
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
