FDA approves additional indication for Dysport

17 June 2017

The US Food and Drug Administration (FDA) has expanded the approved use of Dysport (abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based on its supplemental Biologics License Application (sBLA) in lower limb spasticity.

The announcement on Friday by the drug’s maker, France’s Ipsen (Euronext: IPN), saw the firm’s share rise 3.4% to 120.15 euros.

In July 2015, Dysport® was approved for the treatment of upper limb spasticity in adults. In July 2016, it was cleared to treat pediatric patients with lower limb spasticity aged two and older, making it the first and only botulinum toxin that the FDA approved for this indication. Dysport), which is also used to treat cervical dystonia and glabellar lines, generated revenues of 284.7 million euros ($318 million) in the first quarter of 2017.

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