FDA approves Botox for lower limb spasticity in adults

The US Food and Drug Administration has approved Ireland-incorporated Allergan’s (NYSE: AGN) Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles.

Botox is the first and only botulinum toxin product to be approved by the FDA to treat multiple muscle groups of the upper (elbow, wrist, fingers, and thumb) and lower limbs that may be impacted by spasticity.

Botox was first approved for the treatment of upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers, in adults in March 2010. Additional FDA approval was received in April 2015 to expand the Botox label for the treatment of adults with ULS to include the addition of two thumb muscles.