Allergan's Botox gains expanded US approval to treat upper limb spasticity in paediatric patients

Allergan said Friday that the FDA has expanded the label for Botox (onabotulinumtoxinA) to include treatment of patients aged two years to 17 years with upper limb spasticity. The FDA had granted a priority review designation to Allergan's submission of Botox for this indication earlier this year.

According to the drugmaker, approval was backed by data from two late-stage studies involving more than 200 paediatric patients with upper limb spasticity. David Nicholson, head of R&D at the company, stated that "this milestone...builds on our 30-years of R&D efforts with Botox since FDA approval of blepharospasm and strabismus in 1989."

Allergan said the FDA is also reviewing an additional filing for the use of Botox to treat paediatric patients with lower limb spasticity, with a decision expected in the fourth quarter of this year. The agency previously approved Botox for the treatment of both upper and lower limb spasticity in adults.   

Sales of Botox in the first quarter of 2019 jumped 6.3% year-on-year to $868.4 million, topping expectations.   

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