Prospective Botox® Competitor Gets FDA Approval

Last week, Merz Pharmaceuticals announced the FDA approval of a new challenger to Botox®, Xeomin®.  Xeomin, which contains botulinum toxin type A, was approved for treatment of cervical dystonia (neck spasms) and blepharospasm (eye spasms). 

To date, Dysport® has been the only competitor to Botox®, however, Xeomin® may be the new competition.

Xeomin® is similar to Botox® in that it is injected into the muscle to cease spasms from the nerve. The bacteria Clostridium botulinum produces complex proteins in tandem with the A. Botulinum Toxin A. Xeomin® differs by isolating the therapeutic component from the ancillary complex proteins, allowing more biologic activity and less protein load.

Xeomin®, unlike Botox® and Dysport®, does not require refrigeration to maintain product integrity.

Although Xeomin® is currently only approved for medical purposes, physicians will be able to offer it as an off-label alternative to Botox®. Cosmetic approval should not be far off, considering that active comparator studies conducted in Europe comparing Xeomin® with Botox® were included in the paperwork submitted to the FDA.  Only time will tell if Merz can put a dent in Allergen’s projected $1.36 billion in annual Botox® sales.

To Your Health & Beauty,
Kent V. Hasen, M.D.

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