Merz Gains FDA Approval for Pediatric Use of Xeomin
Merz Therapeutics, with North American headquarters in Raleigh, has gained a new use for Xeomin, its botulinum toxin therapy.
The U.S. Food and Drug Administration approved Merz’s supplemental Biologics License Application for the treatment of patients aged 2 years and older with upper limb spasticity, excluding spasticity caused by cerebral palsy. Spasticity is the disruption of voluntary muscle movement and sometimes is accompanied by discomfort or pain.
“With the need for prolonged treatment, it is critical for children and adolescents with upper limb spasticity to have a long-term flexible treatment option to help manage their condition over time,” said Kevin O’Brien, president of North America, Merz Therapeutics. “We designed our clinical trial program with 12 upper limb muscles to offer the most flexibility of any botulinum toxin, in order to offer patients, caregivers and doctors a safe and effective treatment option that meets the needs of pediatric patients.”
The FDA also granted Xeomin Priority Review for a supplemental Biologics License Application for the treatment of pediatric patients with sialorrhea, or drooling, with an expected decision this December. Sialorrhea is a common problem in neurologically impaired children.
Xeomin, or incobotulinumtoxinA, is proving to be a versatile product for Merz. It is now approved for five first-line, or primary, indications in the United States and has helped more than three million patients worldwide, according to the company.
Xeomin was first approved by the FDA in 2010 for treating blepharospasm, or involuntary blinking, and cervical dystonia, an involuntary contraction of neck muscles. In 2015 it was approved for treating upper limb spasticity, and in 2018 it was approved for treating chronic sialorrhea. All of these indications were for adults.
The latest approval, for upper limb spasticity in children, is the first pediatric indication for Xeomin.
Xeomin is also widely used as a cosmetic treatment for easing frown lines between the eyebrows. It has been approved for that use since 2011 and competes with Botox, a similar botulinum toxin.
The active ingredient in Xeomin is botulinum toxin type A, a protein purified from the bacterium Clostridium botulinum. Xeomin acts on nerve endings in muscles to prevent muscle fibers from contracting.
Merz Therapeutics is a business of Merz Pharmaceuticals, a global healthcare company owned by the Merz Group, a privately held, family-owned company based in Frankfurt, Germany.