AbbVie Submits FDA Application For Continuous, 24-Hour Infusion Therapy For Parkinson's

  • AbbVie Inc ABBV submitted its FDA marketing application for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy. 
  • AbbVie’s theory here revolves around using a continuous, 24-hour infusion of its therapy. The levodopa and carbidopa prodrugs are delivered in small doses subcutaneously through a pump and are designed to activate once they enter the bloodstream.
  • In its pivotal Phase 3 study, AbbVie assessed when the symptoms were well-controlled and when not. The company described these as “On” and “Off” times.
  • The average increase was 2.72 hours of “On” time for patients taking ABBV-951 and 0.97 among those on the standard of care. 
  • Additionally, decreases of “Off” time came in at 2.75 hours in the treatment arm and 0.96 hours in the standard of care group.
  • Both differences were statistically significant.
  • AbbVie noted that the adverse event profile came in largely mild-to-moderate. Most side effects had to do with the infusion site, including pain, skin reddening, inflammation, and bruising.
  • Price Action: ABBV shares are down 1.81% at $148.98 during the market session on the last check Friday.
Posted In: BriefsBiotechLarge CapNewsHealth CareGeneral