Approval of cell-based assay for testing of Botox by FDA

Currently, the FDA as well as other worldwide health organisations requires that all manufacturers protect patients and consumers by guaranteeing product safety and efficacy through animal testing and other methods.

Up to 95 percent reduction​

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Allergan has claimed that the use of the new assay will reduce the use of animal testing by up to an estimated 95 percent, over the course of the next three years, as it hopes to get more regulatory agencies around the world on board to approve this assay.

Allergan’s executive vice president Scott Whitcup commented, “Following the FDA approval, we will work hard to secure approval of the new assay to replace the current animal testing requirements for the release and stability testing of Botox and Botox Cosmetic in countries in which we market and distribute the product.”

Animal testing required​

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Despite animal testing being illegal in many parts of the world, and many companies having taken a stand against the practice, Botox is one of the few compounds, which has an animal testing requirement before it can be released to the general public.

The mouse LD50 potency assaym which is a standard for potency and stability testing of Botox is required by the FDA, the Medicines and Healthcare products Regulatory Agency (MHRA) in Europe, and regulatory agencies worldwide, for testing the final product for release to assure its safety and efficacy.

Allergan has stated to have made numerous attempts over the years to find strategies to replace the animal based LD50 assay for the testing of botulinum neurotoxins, but has fallen short.

A naturally occurring but potent substance, only a very small amount of purified botulinum neurotoxin is used in Botox as the active ingredient; apparently only 1 gm is needed to supply the entire world.

Highly sensitive replacement​

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Allergan has stated that in order to replace LD50, a suitable potency assay sensitive enough to measure the complex mode of action of an extremely small amount of the neurotoxin used in Botox in the cellular level was needed.

The newly approved assay will be implemented immediately for the product’s release for sale in the US.