- AbbVie Inc (NYSE: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.
