Medytox Files Citizen Petition with FDA Requesting Investigation of Application for Botulinum Drug Product
SILVER SPRING, Md.--(BUSINESS WIRE)-- False statements about a botulinum toxin strain and concerns about integrity of data and the impact on patient safety are at the core of a Citizen Petition filed today asking the FDA not to approve the neurotoxin product made by Daewoong Pharmaceutical Co., Ltd. that is the subject of a Biological Product Application (BLA) submitted by Evolus.
South Korean biopharmaceutical company Medytox, Inc., 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.
“Integrity of the data matters because it is the foundation upon which product safety rests,” said Hyunho Jung, Medytox CEO. “The quality and purity of any drug product depend on adequate control of the entire process, starting with identity of the source material and continuing all the way through the manufacturing process. There are glaring incongruities about the strain used for the botulinum product in the Evolus BLA, and therefore we are asking FDA to study and validate the data to assure public health and safety.”
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.
Knowing the identity and source of the strain is essential to ensure the safety, purity, and effectiveness of a neurotoxin product. A false statement about such a material fact calls into question the integrity of other statements and data showing safety and effectiveness in the BLA. In addition, the adequacy of the testing during manufacturing depends on the identity and characteristics of the strain. Medytox is 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.
Dr. Ivan C. Hall was an American researcher who discovered thousands of C. botulinum strains between 1920 and 1942. One of the Type A Hall strains was found to have the ability to produce more toxin per unit of culture than any other strain tested, and became the botulinum neurotoxin strain of choice in basic research and for commercial uses. The Hall strain has been used for the development of biological drug products to treat a variety of neuromuscular disorders, such as Allergan’s Botox brand sold in the United States and Medytox’s Neuronox brand available in South Korea and other markets.
Medytox, Inc. 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. All products have been developed by in-house R&D. Since the approval of Neuronox, Medytox has continued moving forward by maintaining a strong position in medical aesthetics as well as therapeutic indications associated with movement disorder.
Ball Consulting Group, LLC
David Ball, 617-243-9950
Source: Medytox, Inc.