Allergan plc (NYSE: AGN), a leading global pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its Supplemental Biologics License Application (sBLA) for BOTOX® (onabotulinumtoxinA) for the treatment of adults with lower limb (involving ankle and toe muscles) spasticity in adults. A six-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act (PDUFA) date is expected to be in the first quarter of 2016.
"We have continued to work closely with the FDA to prepare our resubmission and we are confident that the additional information requested is addressed," said Mitchell F. Brin, M.D., Senior Vice President Global Development and Chief Scientific Officer, BOTOX®. "This FDA acceptance represents our ongoing commitment to research and development, and efforts to bring to market the first-approved focal therapy for lower limb spasticity for physicians and patients."
The resubmission provides additional data from a double-blind, placebo controlled study involving 468 patients with lower limb spasticity.
In April 2015, the FDA approved an expansion of the BOTOX® (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb; and adductor pollicis, a muscle in the hand that functions to adduct the thumb; increasing the maximum dose from 360 to 400 units for the treatment of upper limb spasticity. The FDA also approved an increase to the maximum BOTOX® cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.