following an abbreviated submission
botulinum toxin type A (Xeomin®) is accepted for use within NHS Scotland.
Indication under review: post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults.
In patients for whom botulinum toxin, type A is an appropriate choice of therapy, this offers an alternative formulation to the comparator product containing conventional botulinum toxin, type A complex.
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Medicine details
- Medicine name:
- botulinum toxin type A (Xeomin®)
- SMC ID:
- 731/11
- Indication:
- Post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults.
- Pharmaceutical company
- Merz Pharma UK Ltd
- BNF chapter
- Central nervous system
- Submission type
- Abbreviated
- Status
- Accepted
- Date advice published
- 10 October 2011
Re: Product Update No: 731/11 dated 9 September 2011.
SMC wishes to draw attention to a variation to the SmPC for Botulinum toxin Type A (Xeomin) approved in February 2012 after Product Update 731/11 had been issued.
SMC has been informed by MHRA that this amendment was requested by some EU member states to avoid possible confusion in relation to potency measurements and interchangeability with other products containing Botulinum toxin type A. In these circumstances SMC wish to draw to your attention the fact that the sentence ”Comparative clinical study results suggest that Xeomin and the comparator product containing conventional Botulinum toxin type A complex (900kD) are of equal potency when used with a dosing conversion ratio of 1:1” has been removed from Section 4.2 of the SmPC. The following wording which MHRA has noted reflect the comparative clinical studies more accurately has been added to Section 5.1 (Pharmacodynamic Properties):
“Non-inferiority of XEOMIN efficacy as compared to a comparator product containing the conventional Botulinum toxin type A complex onabotulinumtoxinA (900 kD) was shown in two comparative single-dosing Phase III studies one in patients with blepharospasm (study MRZ 60201-0003 n=300) and one in patients with cervical dystonia (study MRZ 60201-0013 n=463). Study results also suggest that XEOMIN and this comparator product have a similar efficacy and safety profile in patients with blepharospasm or cervical dystonia when used in a dosing conversion ratio of 1:1 (see section 4.2).”
Prescribers are reminded of the bolded wording in Section 4.2 confirming that unit doses recommended for XEOMIN are not interchangeable with those for other preparations of Botulinum toxin.