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The USA, Canada and Switzerland have already approved the in-vitro test for both medical and cosmetic versions of Botox
Michelle Thew, ECEAE Chief Executive states: “We are pleased that Allergan has achieved approval by the European regulators for the first non-animal based assay for the potency and stability testing of Botox® and Vistabel®. This is a significant step forward. Allergan has shown that it is possible to replace the cruel mouse bioasssay. We now call on those companies manufacturing botulinum toxin products, including Ipsen and Merz, to follow Allergan's lead.”
The traditional animal test for the batch release of all botulinum products uses mice and is designed like the Lethal Dose 50 (LD50) tests. LD50 tests determine the dose at which 50% of the mice would die and involve severe suffering for the animals. Mice are injected into their abdominal cavities with the toxin and then, over three days, are observed to see if they have died or are showing signs that they will die shortly from the toxin.
The ECEAE has long campaigned for an end to the cruel use of animals in botulinum toxin tests and recently welcomed the chance to discuss the next steps in this effort with Allergan. In the recent meeting, Allergan confirmed that the company aims to end all animal testing for the commercial (batch) release of BOTOX®, Botox Cosmetic and VISTABEL® once all stages of regulatory approval has been cleared.
* European countries that have approved the alternative:
For BOTOX®, Ireland serves as the Reference Member State in the Mutual Recognition Procedure. The other countries involved are Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy, Luxemburg, Norway, Portugal, Spain, and Sweden. National licence variations have been filed in the other European Union countries are are thrfore waitng for approval seperately.
For VISTABEL® (called VISTABEX® in Italy), France serves as the Reference Member State covering 29 countries in the EU, namely Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.