FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy

-- Approval Marks 11th BOTOX® Therapeutic Indication and Comes 30 Years After the First Indications Were Approved --

DUBLIN, Ireland I October 24, 2019 I Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental Biologics License Application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy (CP). This marks the 11th BOTOX® therapeutic indication, having been approved for pediatric upper limb spasticity (ULS) earlier this year. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs, and can interfere with movement. The severity can range from mild to severe muscle stiffness. 

"Lower limb spasticity can impact many aspects of a child's life and have a drastic influence on their overall development and quality of life," said David Nicholson, Chief Research and Development Officer, Allergan. "This milestone will continue to support and advance care for children and their caregivers who may be struggling with lower limb spasticity. Here at Allergan, we look forward to continuing to highlight our unwavering attention to innovation and build on our 30-years of research and development efforts with BOTOX®® since FDA approval of blepharospasm and strabismus in 1989." 

The FDA approval is based on a Phase 3 study evaluating the safety and efficacy of BOTOX® in more than 300 pediatric patients aged two to 17 years old being treated for lower limb spasticity. While trial participants had cerebral palsy, the approved indication excludes lower limb spasticity caused by cerebral palsy due to marketing exclusivity by another company. These trials included a 12-week, double-blind study and a one-year open-label extension study.

The approved recommended dose per treatment session is 4 Units per kilogram to 8 Units per kilogram divided among affected muscles of the lower limb.  The total dose per treatment session in the lower limb should not exceed 8 Units per kilogram or 300 Units, whichever is lower. When treating both lower limbs or upper and lower limbs in combination, the total dose in pediatric patients should not exceed 10 Units per kilogram body weight or 340 Units, whichever is lower, in a 3-month interval.

"Pediatric lower limb spasticity inhibits normal muscular movement and function and can result in delayed or impaired motor development, as well as difficulty with posture and positioning," said Mark Gormley, Jr. M.D., Pediatric Rehabilitation Medicine Specialist, Gillette Children's Specialty Healthcare-St. Paul. "BOTOX® has a well-established safety and efficacy profile, and supports children and adolescents successfully manage both their upper and lower limb spasticity."

Allergan is committed to providing resources and services, such as the BOTOX® Savings Program, to help ensure BOTOX® is accessible and affordable to patients.

BOTOX® (onabotulinumtoxinA) Important Information

Indications

BOTOX® is a prescription medicine that is injected into muscles and used:

  • to treat increased muscle stiffness in children 2 to 17 years of age with upper limb spasticity
  • to treat increased muscle stiffness in children 2 to 17 years of age with lower limb spasticity, excluding spasticity caused by cerebral palsy
  • to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older

It is not known whether BOTOX® is safe or effective for other types of muscle spasms.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.

SOURCE: Allergan

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