Merz North America announced that the 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 adults.

The sBLA submission was supported by findings from a Phase 3 multicenter, randomized, double-blind, placebo-controlled trial (N=184) of patients who were administered either incobotulinumtoxinA 75 U, incobotulinumtoxinA 100 U or placebo. At Week 4, treatment with Xeomin resulted in a statistically significant change in unstimulated salivary flow rate (uSFR) from baseline pre-injection (P=0.004), and in the subjects’ Global Impression of Change Scale (GICS) at Week 4 vs placebo (P=0.002). Both co-primary endpoints were achieved.

In addition, the rate of adverse events was comparable between both study arms and no new events were observed. 

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Xeomin, a neuromuscular blocker, is already approved to treat upper limb spasticity in adults, cervical dystonia in both botulinum toxin-naïve and previously treated adult patients, blepharospasm in adults previously treated with onabotulinumtoxinA, and for the temporary improvement in the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date in the 4th quarter of this year. If approved, Xeomin may be the first neurotoxin with this indication in the U.S.

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