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Author Topic: BOTOX: FDA approves Allergan's first in vitro, cell-based potency assay CBPA  (Read 6677 times)
Horst Spielmann
Free University Berlin, Professor for Regulstory Toxicology & retired from ZEBET at the Federal Ist for Risk Assessment
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« on: June 25, 2011, 12:36:15 pm »

On June 24, 2011, .Allergan, Inc. announced that the United States Food and Drug Administration (FDA) has approved a fully in vitro, cell-based assay for use in the STABILITY and POTENCY testing of BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic. The newly approved assay will be implemented immediately for release of product for sale in the United States. Allergan estimates that use of the new assay will reduce the use of animal-based assay testing for BOTOX® and BOTOX® Cosmetic by up to 95 percent or more over the next three years, as other regulatory agencies around the world approve this new assay. The new assay is the first to be developed and approved for any botulinum neurotoxin currently available worldwide, and is specifically applicable to Allergan’s botulinum toxin type A product.
For details please visit http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=587234

It is important that the new cell based assay will allow to replace the BOTOX LD50 test for both STABILITY and POTENCY testing.

It must be noted that the scientific basis of the CBPA (cell based potency assay) has not yet been disclosed by Allergan or the FDA. However, this is essential information, in order to replace LD-50  BoNT potency testing of other producers, who are not using BoNT-A toxin like Allergan but other BoNT toxins.  

Horst Spielmann  


« Last Edit: June 27, 2011, 10:54:47 am by Horst Spielmann » Logged

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Martin Stephens
Johns Hopkins Center for Alternatives to Animal Testing
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« Reply #1 on: June 27, 2011, 05:25:49 pm »

Horst and others,

Here is a copy of a press release that the Humane Society of the United States just issued on this major development:

FOR IMMEDIATE RELEASE

The HSUS and Calvert Investments Applaud Allergan for Developing an Animal-Free Procedure for Testing Botox©

Also Praise U.S. Food and Drug Administration for Approving the New Test

(June 27, 2011) – The Humane Society of the United States and Calvert Investments applaud Allergan’s announcement that the company has developed  – and received federal approval for – a new procedure that avoids using animals in testing batches of Botox© products.  The industry standard for assessing the potency and stability of Botox-like products has been the LD50 test, which subjects animals to considerable suffering and results in death by asphyxiation.  According to an Allergan press release, the company spent more than 10 years and $65 million conducting research to develop the new test and secured approval from the U.S Food and Drug Administration on Friday. The company expects the new method will reduce its use of animals in Botox© testing by 95 percent within three years.

“CEO David Pyott has delivered on his promise that Allergan would invest the money and expertise necessary to develop an animal-free method of testing batches of Botox©,” stated Martin Stephens, Ph.D., vice president for animal research issues for The HSUS. “We now urge Allergan to work with companies that manufacture products with active ingredients similar to that used in Botox©, to see if the new method can be tailored to those products, thereby sparing additional animals.  In the European Union alone, tens of thousands of animals are estimated to be used in this testing per year, and this use has been increasing.”

“We commend Allergan on gaining regulatory approval in the United States for its new test and we welcome the FDA’s approval of the alternative method,” stated Ellen Kennedy, senior sustainability analyst for Calvert Investments, which joined the HSUS in co-filing shareholder resolutions with Allergan to ensure the company’s commitment to progress on this issue.  “We urge Allergan to move expeditiously to secure approvals in Botox© markets outside of the United States.”

Timeline

1927:   The LD50 test is developed to assess the potency and safety of therapeutic agents that vary from batch to batch.  “LD50” stands for Lethal Dose-50 percent and, in a typical LD50 test, around half the animals will die from the effects of the test agent.   

2003:   An exposé by the Fund for the Replacement of Animals in Medical Experiments (UK) indicates that the LD50 test, which is otherwise waning, is used to standardize batches of Botox© and similar products, the demand for which has been growing.

2004:   The HSUS approaches Allergan about its use of animals in Botox© testing in January of 2004, asking the company to replace the LD50 test with appropriate non-animal systems.  In October of 2004, The HSUS appealed to its members to contact Allergan to urge the company to replace the LD50 with a non-animal alternative. 

2007:   Allergan posts a statement on its website about its animal testing, including for Botox©.

2008:   The HSUS and Calvert Investments file a shareholder resolution urging greater transparency in Allergan’s efforts to replace the LD50 test.  At the shareholder meeting, the resolution receives nearly double the number of supportive votes to allow the resolution to be refiled in 2009.

2009:   A second HSUS/Calvert resolution gains enough votes to comfortably exceed the six percent threshold to allow the resolution to be refiled in 2010.  At the shareholder meeting, Allergan CEO David Pyott affirms the company’s commitment to develop a non-animal replacement for the LD50 test.

2010:   The HSUS and Calvert withdraw their third resolution after Allergan revises its website statement on Botox© testing, providing an update on its progress towards developing an alternative test and affirming in writing its commitment to finish the job.


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