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Allergan’s sBLA for Botox for pediatric patients approved by FDA

Allergan PLC said Friday that its supplemental biologics application (sBLA) for Botox for the treatment of upper limb spasticity in pediatric patients, from ages 2 to 17, was approved by the U.S. Food and Drug Administration. Botox was granted a 6-month Priority Review by the FDA. Upper limb spasticity often results in muscle tightness and stiffness, and can interfere with movement at the joints. Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury and stroke. Allergan said the FDA is also reviewing an sBLA for the use of Botox to treatment pediatric patients with lower limb spasticity, and expects a decision by the end of the year. Allergan’s stock, which is still inactive in premarket trade, has fallen 15% over the past three months, while the SPDR Health Care Select Sector ETF has gained 1.1% and the S&P 500 has tacked on 3.5%.Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

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