AbbVie launches Produodopa for advanced Parkinson’s in EU

Produodopa (foslevodopa/foscarbidopa), AbbVie‘s continuous under-the-skin (subcutaneous) infusion formulation of levodopa/carbidopa, now is available in the European Union (EU) for advanced Parkinson’s disease patients whose severe motor fluctuations and involuntary movements are not controlled well with standard therapies. AbbVie initially was granted marketing authorization for Produodopa — also known…

FDA needs additional information before approval of ABBV-951

The U.S. Food and Drug Administration (FDA) has requested more information about the specialized pump used to administer ABBV-951 (foslevodopa/foscarbidopa), an under-the-skin formulation of levodopa/carbidopa, before it will consider approving the therapy for motor fluctuations in people with advanced Parkinson’s disease. The agency’s complete response letter comes 10…

ABBV-951 Found to Help Control Motor Symptoms in Phase 3 Trial

ABBV-951, a continuous infusion formulation of levodopa/carbidopa that’s administered under the skin, improved “on” time and decreased “off” time when compared with standard oral therapy in people with advanced Parkinson’s disease. Those are the results of a randomized Phase 3 clinical trial testing the experimental formulation in more than…

ABBV-951 Extends ‘On’ Time More Than 3 Hours a Day

ABBV-951, AbbVie‘s experimental under-the-skin formulation of levodopa/carbidopa, was generally well-tolerated and increased average “on” time by more than three hours among people with Parkinson’s disease. Those results from a Phase 3 open-label clinical trial were shared at the 8th European Academy of Neurology (EAN) Congress in Vienna, Austria, in…

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…

ABBV-951, Levodopa as Infusion, Seen as Similar to Intestinal Gel

ABBV-951, a continuous infusion formulation of levodopa/carbidopa, brought comparable levels of levodopa into the bloodstream of healthy volunteers as surgically implanted levodopa-carbidopa intestinal gel (LCIG), a Phase 1 study confirmed. Because the delivery of doses can be tailored to a patient’s needs, this alternative form of delivery — a portable…