FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity

Applications Seek to Extend Use of BOTOX® for Patients 2 to 17 Years Old

DUBLIN, Ireland I March 7, 2019 I Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license applications (sBLAs) to expand the BOTOX® (onabotulinumtoxinA) label for the treatment of pediatric patients (2 years of age and older) with upper and lower limb spasticity.  The pediatric upper limb spasticity indication has been designated a 6-month Priority Review with a Prescription Drug User Fee Act (PDUFA) date expected in the second quarter of this year.  The pediatric lower limb spasticity indication will undergo a standard 10-month review with a PDUFA date expected in the fourth quarter of 2019. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs. The most common cause of focal spasticity in children is cerebral palsy, which occurs in an estimated 2.5 per 1,000 live births globally. Nearly all patients with cerebral palsy have impaired motor function, with spasticity affecting as many as 91 percent.

BOTOX® is the first FDA-approved neurotoxin treatment for both upper and lower limb spasticity in adults, 18 years and older. If approved, BOTOX® would be the first neurotoxin treatment indicated for use in both upper and lower limb pediatric spasticity.

"The FDA's acceptance of Allergan's supplemental biologics license applications is a monumental milestone on our journey to bring new treatment options to pediatric patients with upper and lower limb spasticity," said David Nicholson, Chief Research and Development Officer, Allergan. "BOTOX® has been used in a variety of therapeutic areas for the past 30 years since FDA approval of blepharospasm and strabismus, and we remain steadfast in our commitment to investing in research that explores the potential benefits of BOTOX® in treating patients across an array of therapeutic areas."

The sBLA submissions are based on data from four Phase 3 studies evaluating the safety and efficacy of BOTOX® in more than 600 pediatric patients with upper and lower limb spasticity.

"Pediatric spasticity is a significant concern and can negatively impact a child's development and quality of life, interfering with everyday activities such as walking, dressing and playing," said Heakyung Kim, M.D., Pediatric Rehabilitation Medicine at Columbia University Medical Center/New York Presbyterian Hospital. "Spasticity management in pediatrics is critical while children are growing and adaptable. Considering the negative effects of long-term spasticity, it is important to provide continuum of care throughout childhood into adulthood. The positive results for BOTOX® for the treatment of pediatric upper and lower limb spasticity are promising as we look to address unmet and ongoing needs in children and adolescents."


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

  • to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity
  • 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 to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or to treat increased stiffness in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.

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 bold, global pharmaceutical leader. Allergan is 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.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations 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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