AbbVie Files for FDA Approval of ABBV-951 Levodopa Infusion
AbbVie has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for ABBV-951 (foscarbidopa/foslevodopa), its investigational under-the-skin formulation of carbidopa/levodopa for the treatment of motor fluctuations in advanced Parkinson’s disease.
If approved, ABBV-951 will provide patients in the U.S. with a first-of-its-kind, 24-hour, continuous delivery option to supply more stable levels of the carbidopa/levodopa prodrugs. A prodrug is an inactive compound that is converted in the body to an active medication.
The filing came following data from a randomized Phase 3 clinical trial (NCT04380142) that showed that ABBV-951 outperformed immediate-release carbidopa/levodopa capsules given orally for 12 weeks, or about three months, at controlling motor fluctuations. The trial included 130 adults with Parkinson’s from 80 locations across the U.S. and Australia.
It was also supported by data from an ongoing open-label Phase 3 clinical trial (NCT03781167) that is evaluating the long-term safety and efficacy of ABBV-951 when delivered over the course of 52 weeks, or about one year.
“We are committed to addressing the unmet needs of those affected by the disease and recognize the urgency for a new treatment that can enable better symptom control through the continuous 24-hour administration of medication,” Thomas Hudson, MD, senior vice president of research and development at AbbVie, said in a press release. Hudson is also the chief scientific officer at the company.
The company also announced that it plans to file regulatory submissions for ABBV-951 globally throughout the year.
Parkinson’s symptoms occur when the levels of dopamine, a neurotransmitter that helps control movement, become too low. Levodopa works by getting converted in the brain into dopamine. It is often combined with carbidopa, which blocks an enzyme that is involved in the breakdown of levodopa in the body. This combination allows more levodopa to reach the brain and helps reduce its side effects by toning down the required dose.
Even so, over time, the response to levodopa can wear off. This means that its effects fade before it is time for the next dose. Wearing off happens more frequently as the disease progresses into its more advanced stages, causing fluctuations of motor symptoms. Patients who have been taking levodopa for some time may also develop dyskinesia (involuntary movements).
Motor fluctuations and dyskinesia can be difficult to treat with oral medications, and other available options are limited. Levodopa/carbidopa therapy is generally given orally. ABBV-951 is a formulation of this therapy designed for continuous subcutaneous (under-the-skin) infusion, which is expected to provide stable levels of levodopa and extend the amount of “on” time, which occurs when the medication is working well and motor symptoms are controlled.