Foley Hoag Files Citizen Petition with FDA on Behalf of Client Medytox Requesting Investigation of Application for Botulinum Drug Product
December 5, 2017
Foley Hoag LLP filed a Citizen Petition on December 5, 2017 on behalf of client South Korean biopharmaceutical company Medytox, Inc. asking the U.S. Food and Drug Administration (FDA) not to approve the neurotoxin product made by Daewoong Pharmaceuticals Co., Ltd. that is the subject of a Biological Product Application (BLA) submitted by Evolus Inc. False statements about a botulinum toxin strain and concerns about integrity of data and the impact on patient safety are at the core of the petition.
Medytox is the only biopharmaceutical company in the world to have three different types of botulinum toxin products (Neuronox, INNOTOX, Coretox), and Neuronox is only the fourth botulinum toxin therapeutic product approved anywhere in the world.
In its petition, Medytox is asking FDA to determine the true source and identity of the botulinum strain Daewoong is using to make its DWP-450 botulinum toxin product for Evolus, which seeks BLA approval to market in the U.S. Daewoong claims it found a one-of-a kind botulinum strain called “the Hall strain” in soil in South Korea. Scientific evidence, however, shows this unique strain cannot be isolated from any soil.
A BLA must contain true and not misleading data to demonstrate that a biological product meets FDA’s safety, purity, and potency requirements. Medytox’s Citizen Petition raises serious questions about the integrity of the safety and effectiveness data and information Evolus submitted to FDA. The petition asks FDA to invoke its fraud policy, known as the Application Integrity Policy (AIP), and to require submission of the strain’s whole genome sequence to prove its actual source and identity.
The Citizen Petition asks FDA to determine if Daewoong’s DWP-450 product, which it manufactures in South Korea, is in fact made from the Clostridium botulinum toxin Type A Hall strain as Daewoong claims, or whether it is a spore-forming C. botulinum strain actually isolated from soil in South Korea as Daewoong also claims. The Citizen Petition points out that at least one of Daewoong’s claims is untrue. Medytox is also asking FDA to investigate and tell physicians, patients, and the public what is true by ensuring that the product labeling accurately identifies the botulinum strain of the neurotoxin product in Evolus’ BLA.
Medytox's Citizen Petition can be found here.
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