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Switzerland becomes the first country in Europe to approve and accept the new non-animal test for Allergan botulinum toxin products Botox and Vistabel.
The European Coalition to End Animal Experiments (ECEAE) has today welcomed news that SwissMedic has approved Allergan’s fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX® and VISTABEL® Switzerland has become the first European country to do following the recent approval of the non-animal test in the U.S. and Canada.
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.
Aside from the US, Canada, and now Switzerland, other regulators worldwide currently require the cruel LD50 testing before each new commercial batch of botulinum toxin product is released for use in humans.
Allergan previously stated that this new non-animal test will enable the company to reduce animal testing of BOTOX®, BOTOX® Cosmetic and VISTABEL® by up to 95% in three years.
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.
During the meeting, Allergan also disclosed plans to work with the European medicines regulators so that this non-animal assay can be used for the commercial batch release of BOTOX® and VISTABEL® sold in Europe. The company confirmed that it has already filed for approval throughout the EU.
In the US, Allergan has already started selling BOTOX® and BOTOX® Cosmetic that has been tested using the alternative method. The ECEAE is calling on all remaining regulators worldwide to swiftly accept the non-animal alternative test.
Michelle Thew, Chief Executive of the ECEAE stated: “We are delighted that Swiss regulator have approved this non-animal test for BOTOX® and VISTABEL® , thereby sparing the suffering of thousands of animals. This is a significant step forward. Allergan has shown that it is possible to replace the cruel mouse bioasssay. We now call on the European medicines regulators to accept this test for BOTOX® and VISTABEL® sold in the European Union as swiftly as possible, and we demand urgent action from other companies manufacturing botulinum toxin products, including Ipsen and Merz, to develop similar non-animal tests.”