Allergan announced that the Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Applications (sBLAs) for Botox (onabotulinumtoxinA) injection for the treatment of patients aged ≥2 years with upper and lower limb spasticity.
The sBLA submissions were supported by data from four phase 3 studies evaluating the safety and efficacy of Botox in >600 pediatric patients (235 patients with upper limb spasticity due to cerebral palsy or stroke and 384 patients with lower limb spasticity due to cerebral palsy). In the 2 placebo-controlled trials (NCT01603628; NCT01603602), Botox significantly decreased spasticity vs placebo, as measured by the average change from baseline in Modified Ashworth Scale-Bohannon (MAS-B) score.
Botox, an acetylcholine release inhibitor and a neuromuscular blocking agent, is currently approved to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in patients aged ≥18 years with upper and lower limb spasticity. If approved, it would be the first neurotoxin indicated to treat both upper and lower limb pediatric spasticity.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date for the upper limb pediatric spasticity indication in the second quarter of 2019; the PDUFA date for the lower limb pediatric spasticity indication is expected in the fourth quarter of 2019.
For more information visit Allergan.com.