February 27, 2019

Researchers conducted a review of various botulinum neurotoxin type A formulations.

IncobotulinumtoxinA offers an advantage over other botulinum neurotoxin type A (BoNT-A) formulations because it is less likely to induce an immune response when used clinically. A review of various BoNT products was conducted and results were published in the Journal of Drugs in Dermatology.

In 2017, aesthetic dermatologic applications of BoNT formulations, including for treatment of horizontal forehead lines, glabellar lines, and crow’s feet, were the most common nonsurgical cosmetic procedures performed in the United States, with high levels of patient satisfaction reported. Since the first BoNT-A product was approved by the US Food and Drug Administration in 1989, the number of formulations available worldwide has increased, with new approvals anticipated.

It is well known that BoNT is produced by Clostridium botulinum as part of a large protein complex. The unnecessary clostridial proteins do not play a role in clinical applications. Data have demonstrated that BoNT administration can elicit an immune response, leading to the production of neutralizing antibodies that can be related to treatment nonresponse or reduced efficacy. With repeated treatments needed to maintain effectiveness, clinicians must be aware of the potential for antibody development and thus select a BoNT with the lowest risk for immunogenicity.

IncobotulinumtoxinA is purified and manufactured precisely using advanced technology and good manufacturing practice. The unnecessary clostridial proteins are removed using stepwise chromatography to isolate the pure BoNT accurately without any unnecessary clostridial proteins, resulting in high specific activity and low immunogenicity. Clinical studies of incobotulinumtoxinA have shown that participants who had never previously received BoNT did not have neutralizing antibodies or secondary nonresponse to incobotulinumtoxinA therapy.

The investigators concluded that the unique and precise purification of incobotulinumtoxinA represents innovative advances in the BoNT manufacturing process. Currently, incobotulinumtoxinA is the only BoNT formulation in commercial markets across the world that was designed intentionally to contain only the required therapeutic BoNT component.

“The data reviewed here suggest incobotulinumtoxinA offers an advantage over other BoNT-A formulations due to its lower potential to provoke an immune response when used clinically,” the researchers concluded.

Disclosures: Dr Kerscher reports relationships with Galderma/Q-Med, Ipsen, and MErz Pharmaceuticals GmbG. Dr Trindade de Almeida reports relationships with Allergan, Galderma/Q-Med, Lupin, Mantecorp, Merz Pharmaceuticals, and Sinclair. Drs Maas and Frevert report relationships with Merz Pharmaceuticals GmbH.

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Reference

Kerscher M, Wanitphakdeedecha R, Trindada de Almeida AT, Mass C, Frevert J. IncobotulinumtoxinA: a highly purified and precisely manufactured botulinum neurotoxin type A. J Drugs Dermatol. 2019;18(1):52-57.