The United States Food and Drug Administration has approved a fully in vitro cell-based assay developed by Allergan for use in the stability and potency testing of Botox (onabotulinumtoxinA) and Botox Cosmetic. The FDA approval follows more than a decade of research and development by Allergan. As other regulatory agencies around the world approve this new assay, Allergan estimates that it could reduce the use of animal-based assay testing for Botox and Botox Cosmetic by up to 95% or more over the next three years.
“The new cell-based potency assay ... has many advantages over current methods, including the potential for greater precision and consistency in stability and potency testing, making this a significant breaththrough in both the science and manufacturing of neurotoxins,” said Timothy Terrell, senior vice president of drug safety evaluation for Allergan.
The new assay is specifically applicable to Allergan’s botulinum toxin type A product. The company is discussing how to license the technology to other parties.