ChEMBL

We have had a couple of mails about the exclusion of AbobotulinumtoxinA (aka Dysport) as a new NME in some of our analyses of drugs for 2009. This is a subtle case, and our treatment of AbobotulinumtoxinA is as follows - but basically it is not an NME.

Recently the FDA required that, due to the non-interchangeability, and potential safety issues of Botulinum Toxin A products from different manufacturers, that differing non-proprietary names were required for these products, despite the fact that nominally they contain the same active ingredient (in this case a large protein therapeutic). So Botox, marketed by Allergan, now uses the non-proprietary name onabotulinumtoxinA, while for Dysport (approved during 2009) from Ipsen, uses the non-proprietary name abobotulinumtoxinA. Since they essentially just differ by manufacturer, and not by active ingredient, we have not considered Abobotulinum toxin as being a new NME approval.