USFDA accepts Allergan license applications to expand Botox label

"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.

DUBLIN: Allergan plc has recently 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.

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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 per cent.

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.

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"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," he added.

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 paediatrics 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."

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