AbbVie’s Parkinson’s Disease Therapy Rejected by US FDA


AbbVie announced that the FDA has rejected its application for ABBV-951 to control motor fluctuations in advanced Parkinson’s disease patients. Foscarbidopa and foslevodopa, the prodrugs for the widely used carbidopa and levodopa, respectively, are already included in AbbVie’s Duopa as part of the treatment. Prodrugs are versions of drugs that work once they are in the body.

AbbVie stated that although the FDA did not inquire about the efficacy or safety of ABBV-951, it did request additional information regarding the combination’s subcutaneous pump device. The enormous pharmaceutical company based in Illinois stated that it intends to resubmit the application as soon as possible.

In a note published on Wednesday, analysts at Evercore ISI speculated that AbbVie’s biggest new product launches over the next year or two might include ABBV-951. The analysts pushed back their estimated launch date by a year to mid-2024, despite the fact that approval should come eventually.

ABBV-951 may offer more convenience and effectiveness than Duopa. ABBV-951 is designed to be given continuously under the skin with a pump, whereas Duopa comes in a gel form and is taken orally through a stomach tube. According to Evercore analysts, surgery must be performed to insert the tube into the patient’s intestine before Duopa can be started. Doctors have described the procedure as extremely time-consuming.

READ  US FDA Approves Gene Therapy of Bluebird Bio for Rare Neurological Disorder

When compared to oral levodopa/carbidopa at week 12, ABBV-951 significantly increased patients’ time without dyskinesia, indicating that the patients’ involuntary movements were under control. At that point in the trial, ABBV-951’s increase in time was 2.72 hours, while the control arms were 0.96 hours.

Clarivate recently listed ABBV-951 as one of 15 drugs to watch in 2023, with anticipated sales of $880 million in 2027, in light of the combination’s convenience advantage and efficacy profile that were demonstrated in the phase 3 trial. In contrast, Duopa’s worldwide sales in 2022 were $458 million, a 2% decrease year over year at constant currencies.