Ipsen manufactures a prescription drug containing a type A botulinum toxin. It is mainly used to treat a variety of neurological disorders in which patients can suffer from uncontrollable, severely debilitating and sometimes painful muscle cramps. But Azzalure can also be used as a cosmetic product to treat wrinkles.

For batch testing, Ipsen has now introduced the Cell-Based Assay for its products Dysport and Azzzalure for the EU and Switzerland. This means that an estimated 85% of all painful LD50 tests on mice can be replaced. The remaining animal experiments must continue to be carried out on the basis of regulatory requirements for so-called bulk tests and quality checks of the cell culture test itself according to GLP. It is also necessary to carry out LD50 tests if the manufacturer wants to sell its products outside Europe and Switzerland.

In a recent press release, Ipsen states that he is continuing to work on obtaining approval from regulatory authorities worldwide as quickly as possible.

Further information:
https://www.ipsen.com/websites/IPSENCOM-PROD/wp-content/uploads/2018/07/26170420/00-IAW-ONLINE-POSITION-STATEMENT_Ipsen-received-approvals-in-EU-and-CH-FINAL-2018-07-04.pdf