AbbVie's New Drug Application for ABBV-951 in Advanced Parkinson’s Disease Receives Complete Response Letter from FDA

On March 22, AbbVie announced that it had received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for ABBV-951 (foslevodopa / foscarbidopa).

In the letter, the FDA requested AbbVieProvide Additional Information on the ABBV-951 Device (Pump) as Part of the NDA, no additional efficacy and safety trials related to the drug are required. AbbVie stated that it would resubmit the NDA as soon as possible.

The two components of the ABBV-951 compound, foslevodopa/foscarbidopa, are prodrugs of levodopa and carbidopa, respectively, with high water solubility. They can be continuously administered subcutaneously for 24 hours via a pump connected to the subcutaneous tissue, thereby maintaining stable concentrations of levodopa and carbidopa in the body over 24 hours and improving the efficacy fluctuations in patients with advanced Parkinson's disease.

Parkinson's disease is an age-related neurodegenerative disorder characterized by the gradual loss of dopaminergic neurons in the substantia nigra, leading to motor symptoms such as bradykinesia, muscle rigidity, and resting tremors. Levodopa is the most widely used and effective drug for treating Parkinson's disease. However, after long-term use of levodopa-based medications, patients may experience fluctuations in drug efficacy as a side effect. Symptoms can suddenly improve or worsen unpredictably, regardless of medication timing or blood drug concentration, which is clinically referred to as the "on-off phenomenon."

Results from the Phase III Head-to-Head M15-736 Study showed that subcutaneous injection of ABBV-951 significantly extended the "on" time without troublesome dyskinesia in advanced Parkinson's disease patients compared to oral immediate-release levodopa/carbidopa (LD/CD). At week 12 of treatment, the "on" time increased by 2.72 hours in the ABBV-951 group and by 0.97 hours in the oral LD/CD group (p=0.0083). Improvement in "on" time was observed as early as week 1 in the ABBV-951 group and persisted through week 12.

Moreover, at Week 1, compared with the oral LD/CD group, the treatment group showed a similar improvement in "off" time from baseline, which persisted for 12 weeks. At Week 12, the ABBV-951 group experienced a 2.75-hour reduction in "off" time, while the oral medication group had a 0.96-hour reduction.

Most adverse events in the ABBV-951 group were not serious or were mild to moderate. One death due to a treatment-related adverse event was reported in the oral LD/CD group, while no deaths occurred in the ABBV-951 group. The most common (≥5%) adverse events in the ABBV-951 group included infusion site adverse events (erythema, pain, cellulitis, edema, bruising, bleeding, nodules, induration, infection, and pruritus), dyskinesia, "ON" and "OFF" phenomena, falls, hallucinations (including visual hallucinations), balance disorders, constipation, and peripheral swelling.

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