FDA accepts application for Botox to treat paediatric patients with upper and lower limb spasticity

Allergan plc announced that the 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 sBLA submissions are based on data from four Phase III studies evaluating the safety and efficacy of Botox in more than 600 pediatric patients with upper and lower limb spasticity.