RALEIGH, N.C., March 9, 2018
Merz North America announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA) for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients. The sBLA is based on a Phase III study, which met both of its coprimary endpoints for subjects administered 100 U incobotulinumtoxinA by achieving statistically significant change in unstimulated salivary flow rate (uSFR), and in the subjects’ Global Impression of Change Scale (GICS). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in Q4 2018, and if approved, has the potential to make Xeomin the first neurotoxin with this indication in the U.S.
“Sialorrhea is a common problem among people living with neurological disorders, causing added physical and psychosocial challenges for patients as well as caregivers,” said David Dobrowski, Vice President of Research and Development, Merz North America. “We believe Xeomin can help manage excessive drooling, and we look forward to continuing to work closely with the FDA as they review our application.”
The sBLA is based on a Phase III, randomized, double-blind, placebo-controlled, multicenter 184 subject trial. Both co-primary endpoints were successfully achieved. A statistically significant improvement was observed in change in uSFR at week four as compared to baseline pre-injection, for subjects administered 100 U incobotulinumtoxinA vs. placebo, and in the subjects’ GICS at week four for subjects administered 100 U incobotulinumtoxinA vs. placebo (p=0.004 and p=0.002, respectively). GICS is a commonly used rating system for treatments of neurological disorders by clinicians. Overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Subjects enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).
Results of the study were presented at last year’s International Congress of Parkinson’s Disease and Movement Disorders (MDS), American Academy of Physical Medicine and Rehabilitation (AAPM&R) and American Congress of Rehabilitation Medicine (ACRM) annual meetings.
http://www.merzusa.com/news/merz-turns-110-and-continues-its-success-story/